Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

As required by 505A(k)(1) and 505B(h)(1) of the Federal Food, Drug, & Cosmetic Act (BPCA and PREA, respectively), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the Best Pharmaceuticals for Children Act (BPCA) and pediatric assessments conducted under PREA. Total Number of Products Studied under BPCA = 86 Total Number of Products assessed under PREA = 530 Total Number of Products Studied or assessed under Both = 83 Drug SponsorSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or BothAbametapir - XeglyzeHatchtech Pty Ltd Medical (PDF - 4 MB) Addendum (PDF - 78 KB) CDTL (PDF - 3 MB) Resubmission (PDF - 77 KB) DD (PDF - 2 MB) Clinical pharmacology (PDF - 6 MB)Statistical (PDF - 207 KB)PREAAbacavir and Lamivudine - EpzicomViiV Healthcare CompanyMedical (PDF - 3 MB)Clinical pharmacology (PDF - 158 KB)Statistical (PDF - 693 KB)PREAAbacavir and lamivudine - NoneMylan Laboratories Limited, a Viatris CompanyMedical (PDF - 211 KB)NoneNonePREAAbacavir, Dolutegravir, and Lamivudine - TriumeqViiV Healthcare CompanyMedical (PDF - 443 KB)Clinical pharmacology (PDF - 128 KB)NonePREAAbacavir, Dolutegravir, and Lamivudine - Triumeq ViiV Healthcare Company c/o GlaxoSmithKline Medical (PDF - 389 KB) CDTL (PDF - 798 KB) Clinical pharmacology (PDF - 128 KB)NonePREAAbacavir, Dolutegravir, and Lamivudine - Triumeq PDViiV Healthcare CompanyCDTL (PDF - 758 KB)Clinical pharmacology (PDF - 3 MB)NoneBOTHAbacavir sulfate - ZiagenViiV Healthcare CompanyMedical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 5 MB)PREAAbatacept - OrenciaBristol-Myers Squibb Company Medical (PDF - 259 KB) Medical Addendum (PDF - 469 KB) Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 269 KB) NoneBOTHAbatacept - OrenciaBristol-Myers Squibb CompanyMedical (PDF - 4 MB)NoneNoneBPCAAbobotulinumtoxinA - DysportIpsen Bipharm LimitedCDTL Review (PDF - 2 MB) Medical (PDF - 3 MB)NoneStatistical (PDF - 2 MB)PREAAbobotulinumtoxinA - DysportIpsen Bipharm LimitedMedical (PDF - 1 MB)NoneStatistical (PDF - 857 KB)PREAAbrocitinib - Cibinqo Pfizer Inc.Medical (PDF - 10 MB)NoneNonePREAAbrocitinib - CibinqoPfizer Inc.Medical (PDF - 5 MB)NoneNonePREAAcetaminophen - OfirmevMallInc.krodt, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 378 KB)BOTHAcetylcysteine - LegubetiGalephar Pharmaceutical Research Inc. Unireview (PDF - 6 MB) Unireview CR (PDF - 10 MB) NoneNonePREAAcyclovir 5%, hydrocortisone 1% - Xerese Valeant International BermudaMedical (PDF - 885 KB)NoneNonePREAAdalimumab-adaz - Hyrimoz Sandoz Inc. Medical (PDF - 2 MB) CDTL Review (PDF - 300 MB) NoneNonePREAAdalimumab-adaz - HyrimozSandoz Inc.CDTL Review (PDF - 342 KB)NoneNonePREAAdalimumab-adaz - HyrimozSandoz Inc.CDTL Review (PDF - 34 KB)NoneNonePREAAdalimumab-afzb - Abrilada Pfizer Inc.CDTL (PDF - 34 KB)NoneNonePREAAdalimumab-afzb - Abrilada Pfizer Inc.Medical (PDF - 1 MB)NoneNonePREAAdalimumab-afzb - AbriladaPfizer Inc.CDTL (PDF - 34 KB)NoneNonePREAAdalimumab-aqvh - Yusimry Coherus BioSciences, IncMedical (PDF - 5 MB)NoneNonePREAAdalimumab-aqvh - YusimryCoherus BioSciences, IncCDTL Review (PDF - 342 KB)Clinical pharmacology (PDF - 22 KB)NonePREAAdalimumab-atto - AmjevitaAmgen Inc.CDTL Review (PDF - 4 MB) Medical (PDF - 199K KB) Medical (PDF - 336KB) DD Summary Review (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 416 KB) Statistical (PDF - 363 KB) Statistical (PDF - 717 KB) PREAAdalimumab-aaty - YuflymaCelltrion, Inc.CDTL - DD (PDF - 356 KB)Clinical pharmacology (PDF - 2 MB)NonePREAAdalimumab-atto - AmjevitaAmgen, IncCDTL (PDF - 580 KB)NoneNonePREAAdalimumab-atto - AmjevitaAmgen, IncMedical (PDF - 532 KB)NoneNonePREAAdalimumab-atto - Amjevita Amgen, IncMedical (PDF - 532 KB)NoneNonePREAAdalimumab-bwwd - HadlimaSamsung Bioepis Co., Ltd.Medical (PDF - 34 KB)Clinical pharmacology (PDF - 1 MB)NonePREAAdalimumab-bwwd - HadlimaSamsung Bioepis Co., Ltd.Medical (PDF - 34 KB)NoneNonePREAAdalimumab-bwwd - HadlimaSamsung Bioepis Co., LtdMedical (PDF - 34 KB)NoneNonePREAAdalimumab-fkjp - HulioMylan Pharmaceuticals Inc.Medical (PDF - 2 MB)NoneNonePREAAdalimumab-fkjp - Hulio Mylan Pharmaceuticals Inc.Medical (PDF - 580 KB)NoneNonePREAAdalimumab-fkjp - HulioMylan Pharmaceuticals Inc.CDTL (PDF - 24 KB)NoneNonePREAAdalimumab - HumiraAbbVie,Inc.Medical (PDF - 2 MB)NoneNonePREAAdalimumab-aacf - IdacioFresenius Kabi USA, LLCMedical (PDF - 20 MB)NoneNonePREAAdalimumab-aacf - IdacioFresenius Kabi USA, LLCMedical (PDF - 20 MB)NoneNonePREAAdalimumab-ryvk - SimlandiAlvotech USA IncMedical (PDF - 724 KB)NoneNonePREAAdapalene and benzoyl peroxide - EpiduoGalderma Laboratories, LPMedical (PDF - 2 MB)Clinical pharmacology (PDF -124 KB)Statistical (PDF - 577 KB)PREAAdapalene and benzoyl peroxide - Epiduo ForteGalderma Research and Development LLCMedical (PDF - 6.2 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)PREAAfatini - GilotrifBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNoneBPCAAflibercept - Eylea Regeneron Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 5 MB)BPCAAnidulafungin - EraxisVicuron Holdings LLC, a subsidiary of Pfizer Inc.Medical (PDF - 5 MB)NoneNonePREAAlbuterol and Budesonide - Airsupra Bond Avillion 2 Development LPMedical (PDF - 12 MB)NoneNonePREAAlbuterol sulfate - ProAir RespiClickTeva Pharmaceutical Products R. & D., Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)PREAAlbuterol sulfate - ProAir RespiClick Teva Branded Pharmaceutical Products R&D, Inc.Medical (PDF - 859 KB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREAAlirocumab - PraluentRegeneron Pharmaceuticals, IncMedical (PDF - 859 KB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREAAliskiren - TekturnaNoden Pharma DACCDTL (PDF - 310 KB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 442 KB)BOTHAlogliptin - NesinaTakeda Pharmaceuticals U.S.A., IncMedical (PDF - 6 MB)Clinical pharmacology (PDF - 937 KB)Statistical (PDF - 536 KB)PREAAlogliptin and metformin - KazanoTakeda Pharmaceuticals U.S.A., Inc.Medical (PDF - 6 MB)Clinical pharmacology (PDF - 937 KB)Statistical (PDF - 536 KB)PREAAmlodipine benzoate - KaterziaSilvergate Pharmaceuticals, IncMedical (PDF - 46 KB)Clinical pharmacology (PDF - 337 KB)NonePREAAmlodipine - SdamloBrillian Pharma Inc.CDTL - DD (PDF - 578 KB)Clinical pharmacology (PDF - 2 MB)NonePREAAmphetamine - Adzenys ERNeos Therapeutics, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 4 KB)NonePREAAmphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT Neos Therapeutics, Inc.Medical (PDF - 470 KB)Clinical pharmacology (PDF - 3 MB)NonePREAAmphetamine - Dyanavel XRTris PharmaMedical (PDF - 2 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 767 KB)PREAAmphetamine - Dyanavel XRTris Pharma Medical (PDF - 848 KB) CDTL Review (PDF - 1 MB) NoneNone PREAAmphetamine sulfate - EvekeoArbor Pharmaceuticals, LLC Medical (PDF - 1 MB) Medical (PDF - 155 KB) Clinical pharmacology (PDF - 9 KB) Clinical pharmacology memo (PDF - 9 KB) Statistical (PDF - 532 KB)PREAApixaban - Eliquis Bristol-Myers Squibb CompanyMedical (PDF - 6 MB)NoneNonePREAApremilast - OtezlaAmgen, IncMedical (PDF - 7 MB)NoneNoneBOTHApremilast - OtezlaAmgen, IncMedical (PDF - 7 MB)NoneNonePREAAprepitant - EmendMerck Sharp & Dohme Corp.Medical (PDF - 6 MB) Medical Addendum (PDF - 1 MB) Medical DD memo (PDF - 3 MB)Clinical pharmacology (PDF - 5 MB) Clinical pharmacology addendum (PDF - 424 KB)Statistical (PDF - 1 MB)PREAAprepitant - EmendMerck Sharp & Dohme Corp.Medical (PDF - 553 KB)Clinical pharmacology (PDF - 5 MB) Addendum (PDF -105 KB)Statistical (PDF - 1 MB)PREAAripiprazole - AbilifyOtsukaMedical (PDF - 2 MB)NoneStatistical (PDF - 409 KB)PREAAripiprazole - MezofyCMG Pharmaceutical Co., Ltd CDTL (PDF - 251 KB) Medical (PDF - 1 MB) NoneNonePREAAripiprazole - OpipzaXiamen LP Pharmaceutical Co., Ltd.Medical (PDF - 2 MB)NoneNonePREAArticaine ophthalmic solution - CyklxAmerican Genomics, LLC Medical (PDF - 453 KB) CDTL-DD (PDF - 1 MB) Clinical pharmacology (PDF - 519 KB)Statistical (PDF - 767 KB)PREAAsenapine - SaphrisForest Laboratories, Inc.Medical (PDF - 5 MB) Medical (PDF - 4 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 3 MB)BOTHAsparaginase erwinia chrysanthemi (recombinant)- rywn - RylazeJazz Pharmaceuticals Ireland LimitedMedical (PDF - 4 MB)NoneNonePREAAtazanavir and cobicistat - EvotazBristol-Myers Squibb CompanyCDTL (PDF - 402 KB)Clinical pharmacology (PDF - 1 MB)NonePREAAtazanavir - ReyatazBristol-Myers Squibb CompanyMedical (PDF - 14 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 2 MB)BOTHAtazanavir - Reyataz Bristol-Myers Squibb CompanyMedical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 4 MB)BOTHAtezolizumab - TECENTRIQGenentech, Inc.Medical (PDF - 1 MB)NoneNoneBPCAAtezolizumab - TecentriqGenentech, Inc.Medical (PDF - 3 MB)NoneNoneBPCAAtorvastatin calcium - AtorvaliqCMP Development LLCMedical (PDF - 3 MB)Clinical pharmacology (PDF - 1 MB)NonePREAAtropine-pralidoxime - DueDoteMeridian Medical Technologies, Inc. CDTL (PDF - 402 KB) Medical (PDF - 886 KB) Clinical pharmacology (PDF - 1 MB)NonePREAAtropine Sulfate - Isopto Atropine 1%Alcon Research, Ltd.Medical (PDF - 663 KB)Clinical pharmacology (PDF - 480KB)Statistical (PDF - 230 KB)PREAAtropine Sulfate Ophthalmic SolutionAkorn, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 287 KB)PREAAxitinib - InlytaPF PRISM C.V.Medical (PDF - 849 KB)Clinical pharmacology (PDF - 2 MB)NoneBOTHAzelastine hydrochloride - AsteproMeda PharmaceuticalsClinical (PDF - 1 MB)NoneStatistical (PDF - 473 KBPREAAzelastine hydrochloride - AsteproMeda Pharmaceuticals Inc.Medical (PDF - 2 MB)NoneNoneBOTHAzelastine hydrochloride and Fluticasone propionate - DymistaMeda Pharmaceuticals, Inc.Medical (PDF - 3 MB)NoneStatistical (PDF - 2 MB)BOTHBaclofen - FleqsuvyAzurity Pharmaceuticals, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 367 KB)NonePREABaclofen - LyvispahSaol Therapeutics Research LimitedMedical (PDF - 2 MB)Clinical pharmacology (PDF - 448 KB)NonePREABaloxavir marboxil - Xofluza Shionogi, Incorporated CDTL (PDF - 869 KB) Medical (PDF - 414 KB) Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 2 MB) PREABaloxavir marboxil - XofluzaGenentech, Incorporated CDTL (PDF - 853 KB) Medical (PDF - 6 MB KB) Clinical pharmacology (PDF - 420 KB)NonePREABaloxavir marboxil - XofluzaGenentech, IncorporatedMedical (PDF - 11 MB)NoneNonePREABaloxavir marboxil - XofluzaGenentech, IncorporatedMedical (PDF - 248 KB)NoneNonePREABarium sulfate - E-Z-DISKBracco Diagnostics Inc. Medical (PDF - 12 KB) DD Summary Review (PDF - 233 57 KB) NoneNonePREABarium sulfate - E-Z-HD Bracco Diagnostics Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF -642KB)Statistical (PDF -988KB)PREABarium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE Bracco DiagnosticsMedical (PDF - 2 MB)Clinical pharmacology (PDF - 702 KB)Statistical (PDF -1 MB)PREABarium sulfate - Varibar PuddingBracco Diagnostics, Inc.Medical (PDF - 1 MB)NoneNone PREABarium sulfate - Liquid E-Z-PaqueBracco Diagnostics, Inc.DD Summary Review (PDF - 233 KB)NoneNonePREABeclomethasone dipropionate - QnaslTeva Branded Pharmaceutical Products R&D, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF -959 KB)PREABelimumab - BenlystaGlaxoSmithKline (GSK) LLCMedical (PDF - 5 MB)NoneNonePREABelimumab - BenlystaGlaxoSmithKline (GSK) LLCMedical (PDF - 5 MB)NoneNonePREA Belumosudil - Rezurock Kadmon Pharmaceuticals, LLCMedical (PDF - 7 MB)NoneNonePREABelimumab - Benlysta Human Genome SciencesMedical (PDF - 6 MB)NoneNonePREABelimumab - BenlystaGlaxoSmithKline LLCMedical (PDF - 7 MB)NoneNonePREABelimumab - BenlystaGlaxoSmithKline (GSK) LLCMedical (PDF - 8 MB)NoneNonePREABelzutifan - WeliregMerck Sharpe & Dohme LLCMedical (PDF - 12 MB)NoneNonePREABenralizumab - FasenraAstraZeneca ABMedical (PDF - 2 MB)Clinical pharmacology (PDF - 7 MB)Statistical (PDF - 2 MB)PREABenralizumab - FasenraAstraZeneca AB c/o AstraZeneca Pharmaceuticals LP Medical (PDF - 7 MB) Unireview (PDF - 11 KB) NoneNonePREABerdazimer - ZelsuvmiLNHC, Inc.Medical (PDF - 12 MB)NoneNonePREABezlotoxumab - Zinplava Merck Sharp & Dohme Corp.Medical (PDF - 2 MB)NoneNoneBOTHBictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy Gilead Sciences, Inc. CDTL (PDF - 157 KB) CDTL 1 (PDF - 2 MB) Clinical pharmacology (PDF - 2 MB)NoneBOTHBictegravir, emtricitabine, and tenofovir alafenamide - BiktarvyGilead Sciences, Inc. CDTL (PDF - 2 MB)Clinical pharmacology (PDF - 4 MB)NoneBOTHBimatoprost ophthalmic solution, 0.03% - LatisseAllergan, Inc.DD Summary Review (PDF - 966KB) CDTL Review (PDF - 3 MB) Medical (PDF - 2 MB)NoneStatistical (PDF -946KB) Statistical Addendum (PDF - 127KB)PREA Blinatumomab - Blincyto Amgen, Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF -1 MB)Statistical (PDF - 374 KB)BPCABlinatumomab - BlincytoAmgen, Inc.Medical (PDF - 9 MB) None NoneBPCABortezomib - VelcadeMillennium Pharmaceuticals, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 374 KB)BPCABosutinib - BOSULIFPF Prism C.VMedical (PDF - 10 MB)NoneNoneBPCABudesonide - Entocort ECElan Pharma InternationalMedical (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)PREABrensocatib - BrinsupriInsmed IncorporatedMedical (PDF - 21 MB)NoneNonePREABrentuximab vedotin - AdcetrisSeagen Inc.Medical (PDF - 1 MB)NoneNoneBPCABrexanolone - ZulressoSage Therapeutics, Inc.Medical (PDF - 1 MB)NoneNonePREABrexpiprazole - Rexulti Otsuka Pharmaceutical Company, Ltd.Medical (PDF - 4 MB)NoneNonePREABrexpiprazole - Rexulti Otsuka Pharmaceutical Company, Ltd. C/O Otsuka Pharmaceutical Development & Commercialization, Inc.Medical (PDF - 3 MB)NoneNoneBPCABrexpiprazole - RexultiOtsuka Pharmaceutical Company Ltd.Medical (PDF - 3 MB)NoneNonePREABrimonidine tartrate - LumifyBausch + LombCDTL Review (PDF - 3 MB) Medical (PDF - 556 KB)Clinical pharmacology (PDF - 51 KB)Statistical (PDF - 219 KB)PREABrivaracetam - Briviact UCB, Inc. CDTL Review (PDF - 297 KB) Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB)None PREA Brivaracetam - Briviact UCB, Inc.Medical (PDF - 74 KB)Clinical pharmacology (PDF - 2 MB)NonePREABudesonide/formoterol fumarate dehydrate - SymbicortAstraZeneca Pharmaceuticals, LPMedical (PDF - 3.4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 3 MB)BOTHBupivacaine - ExparelPacira Pharmaceuticals, Inc.Medical (PDF - 6 MB)Clinical pharmacology (PDF - 2 MB)NonePREABuprenorphine - ButransPurdue Pharma L.P.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2 MB)NonePREACabazitaxel - JevtanaSanofi-Aventis U.S., L.L.C.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)NoneBPCACabotegravir - ApretudeViiV Healthcare CompanyMedical (PDF - 8 MB)NoneNonePREACabotegravir - ApretudeViiV Healthcare CompanyMedical (PDF - 8 MB)Clinical pharmacology (PDF - 1 MB)NonePREACabotegravir-rilpivirine - Cabenuva ViiV Healthcare CompanyMedical (PDF - 35 KB) Clinical pharmacology (PDF - 1 MB) Clinical pharmacology Addendum (PDF - 229 KB) NonePREACabotegravir and rilpivirine - CabenuvaViiV Healthcare CompanyMedical (PDF - 525 KB)Clinical pharmacology (PDF - 5 MB)NonePREACabotegravir - VocabriaViiV Healthcare Company CDTL (PDF - 1 MB) Medical (PDF - 525 KB) Clinical pharmacology (PDF - 2 MB) Addendum (PDF - 115 KB) NonePREACabotegravir - VocabriaViiV Healthcare CompanyMedical (PDF - 525 KB)Clinical pharmacology (PDF - 5 MB)NonePREACabozantinib - CabometyxExelixis, Inc.Medical (PDF - 9 MB)NoneNonePREACalcipotriene - SORILUXMayne Pharma LLCMedical (PDF - 525 KB)Clinical pharmacology (PDF - 1 MB)NonePREACalcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/SMedical (PDF -6 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 564 KB)PREACalcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/S c/o LEO Pharma, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)NonePREACalcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/SMedical (PDF - 775 KB)Clinical pharmacology (PDF - 528 KB)NonePREACalcipotriene and betamethasone - EnstilarLEO Pharma A/SMedical (PDF - 775 KB)NNoneBOTHCalcium Gluconate injection - Calcium Gluconate InjectionFresenius Kabi USA, LLC Medical (PDF - 4 MB) Medical CTDL (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB)NonePREACalcipotriene - SORILUX FoamMayne Pharma LLCMedical (PDF - 525 KB)NoneNonePREACalcitriol - Vectical Galderma Laboratories, L.P.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 1 MB)NonePREACanagliflozin - InvokanaJanssen Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 828 KB)BPCACanagliflozin and Metformin Hydrochloride - Invokamet Janssen Pharmaceuticals, Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 1 MB)BPCACanagliflozin and metformin - Invokamet XRJanssen Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 828 KB)BPCACantharidin - YcanthVerrica Pharmaceuticals Inc.Medical (PDF - 3 MB)NoneNonePREACapecitabine - XelodaHoffmann-La Roche, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 610 KB)BPCACarbinoxamine maleate - Karbinal ERTris Pharma, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 500 KB)NonePREACarfilzomib - KyprolisOnyx Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNoneBPCACefazolin sodium and dextrose solution - Cefazolin for Injection USP and Dextrose Injection USP in the Duplex® ContainerB. Braun Medical Inc.Medical (PDF - 1 MB)NoneNonePREACefazolin in Dextrose Injection - Cefazolin in Dextrose InjectionBaxter Healthcare CorporationMedical (PDF - 435 KB)Clinical pharmacology (PDF - 1 MB)NonePREACeftaroline fosamil - Teflaro Cerexa, Inc., A Subsidiary of Forest Laboratories, LLCMedical (PDF - 11 MB) Medical CTDL (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREACeftaroline fosamil - Teflaro Allergan Sales, LLCMedical (PDF - 5 MB)NoneNonePREACeftazidime and Avibactam - AvycazAllergan Sales, LLCMedical (PDF - 5 MB)NoneNonePREACeftazidime and avibactam - Avycaz Allergan Sales, LLCMedical (PDF - 4 MB)NoneNonePREACeftazidime and avibactam - AvycaAbbVie, Inc.Medical (PDF - 4 MB)NoneNonePREACeftobiprole medocaril sodium for injection - ZevteraBasilea Pharmaceutica International, Ltd., AllschwilMedical (PDF - 4 MB)NoneNonePREACeftolozane and tazobactam - Zerbaxa Cubist Pharmaceuticals, LLCMedical (PDF - 8 MB)NoneNonePREACemiplimab-rwlc - Libtayo NEWRegeneron Pharmaceuticals, Inc.Medical (PDF - 26 KB)Clinical pharmacology (PDF - 2 MB)NoneBPCACertolizumab pegol - CimziaUCB, IncMedical (PDF - 4 MB)NoneNonePREACertolizumab pegol - CimziaUCB, IncMedical (PDF - 4 MB)NoneNonePREACetirizine ophthalmic solution - Zerviate Nicox Ophthalmics, Inc. Medical Resubmission (PDF - 231 KB) Medical (PDF - 5 MB) Clinical pharmacology (PDF - 279 KB)Statistical (PDF - 580 KB)BOTHCetirizine hydrochloride - QuzyttirJDP Therapeutics IncMedical (PDF - 2 MB)NoneNonePREACiclesonide - ZetonnaTakeda GmbHMedical (PDF - 5 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 674 KB)PREACinacalcet hydrochloride - Sensipar CDTL (PDF - 2 MB) Medical (PDF - 4 MB) Clinical pharmacology (PDF - 6 MB)Statistical (PDF - 957 KB)BOTHCiprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic SolutionLaboratorios SALVAT, S.A.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 632 KB)Statistical (PDF - 2 MB)PREACiprofloxacin otic suspension - Otiprio Otonomy, Inc.Medical (PDF - 233 KB)Clinical pharmacology (PDF - 79 KB)Statistical (PDF - 213 MBPREA6% Ciprofloxacin Otic Suspension - OtiprioOtonomy, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 97 KB)Statistical (PDF - 896 KB) Addendum (PDF - 157 KBPREACiprofloxacin ophthalmic solution - CiloxanNovartis Pharmaceuticals Corporation Medical (PDF - 110 KB) Medical (PDF - 173 KB) NoneNoneBPCA Clascoterone - WinleviCassiopea SpAMedical (PDF - 3 MB)NoneNonePREAClesrovimab-cfor - EnflonsiaMerck Sharp & Dohme LLCMedical (PDF - 8 MB)NoneNonePREAClindamycin phosphate, adapalene, and benzoyl peroxid - CabtreoBausch Health US, LLCMedical (PDF - 4 MB)NoneNonePREAClindamycin phosphate - Xaciato Daré Bioscience Inc.Medical (PDF - 3 MB)NoneNonePREAClonidine hydrochloride extended-release oral suspension - Onyda XRTris Pharma, Inc.Medical (PDF - 3 MB)NoneNonePREAClonidine - KapvayConcordia Pharms Inc.Medical (PDF - 3 MB)NoneStatistical (PDF - 2 MB)PREACobicistat - TybostGilead Sciences, Inc.CDTL (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NoneBOTHCobicistat - Tybost Gilead Sciences, Inc.CDTL (PDF - 4 MB)NoneNonePREACobimetinib - Cotellic Genentech, Inc.Medical (PDF - 27 KB)Clinical pharmacology (PDF - 543 KB)NoneBPCAColesevelam HCl - WelcholDaiichi Sankyo Inc.CDTL (PDF - 2 MB) Medical (PDF - 12 MB)Clinical pharmacology (PDF - 7 MB)NonePREAColesevelam HCl - WelcholDaiichi Sankyo Inc.Medical (PDF - 3 MB)NoneStatistical (PDF - 308 KB)PREACrisaborole Ointment, 2% - EucrisaAnacor Pharmaceuticals Inc.CDTL Review (PDF - 2 MB) Medical (PDF - 12 MB)Clinical pharmacology (PDF - 7 MB)Statistical (PDF - 1 MB)PREACrisaborole - EucrisaAnacor Pharmaceuticals, LLC.Medical (PDF - 2 MB)NoneNonePREACrisaborole - EucrisaPfizerMedical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NoneBOTHCysteamine bitartrate - ProcysbiRaptor Pharmaceuticals, Inc.Medical (PDF - 12 MB)Clinical pharmacology (PDF - 2 MB) Clinical pharmacology addendum (PDF - 420 KB)NoneBPCACysteamine bitartrate - ProcysbiHorizon Pharma USA, Inc. Medical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)BPCACysteamine hydrochloriden - CYSTADROPSRecordati Rare Diseases Inc.Medical (PDF - 294 KB)NoneNonePREADabigatran etexilate - Pradaxa Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF - 2 MB) Medical (PDF - 700 KB) Clinical pharmacology (PDF - 5 MB)NoneBOTHDabrafenib - TafinlarNovartis Pharmaceuticals CorporationMedical (PDF - 18 MB)NoneNoneBPCADabrafenib - TafinlarNovartis Pharmaceuticals CorporationMedical (PDF - 10 MB) CDTL (PDF - 1 MB)Clinical pharmacology (PDF - 579 KB)NoneBPCADalbavancin hydrochloride - DalvanceAllergan Sales, LLCMedical (PDF - 2 MB)NoneNonePREADalteparin sodium - FragminPharmacia & Upjohn, a subsidiary of Pfizer Inc.Medical (PDF - 4 MB)NoneNonePREADarunavir, cobicistat, emtricitabine, and tenofovir alafenamide - SymtuzaJannsenMedical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)NonePREADapagliflozin - FarxigaAstraZeneca AB C/O: AstraZeneca Pharmaceuticals LPMedical (PDF - 5 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)BPCADapagliflozin and metformin hydrochloride - Xigduo XRAstraZeneca AB C/O: AstraZeneca Pharmaceuticals LPMedical (PDF - 5 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)BPCADapsone - AczoneAllergan, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2.6 MB)Statistical (PDF - 1 MB)PREADapsone - AczoneAlmirall, LLCMedical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)NonePREADaptomycin - CubicinCubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp.Medical (PDF - 505 KB)Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 2 KB) Statistical Addendum (PDF - 96 KB)PREADaptomycin - CubicinCubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp.Medical (PDF - 389 KB) Clinical pharmacology (PDF - 991 KB) Clinical pharmacology Addendum (PDF - 80 KB) Statistical (PDF - 374 KB) PREA Daptomycin - Dapzura RT Baxter Healthcare CorporationMedical (PDF - 2 MB)NoneNonePREADarbepoetin alfa - AranespAmgen Inc.Medical (PDF - 2 MB)NoneStatistical (PDF - 280 KB)BPCADarunavir/Cobicistat - PrezcobixJanssen Products, LPMedical (PDF - 10 MB)NoneNoneDarunavir and Cobicistat - PrezcobixJanssen Products, LPMedical (PDF - 147 KB)Clinical pharmacology (PDF - 20 KB)NonePREADarunavir - PrezistaJanssen Products, L.P.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NonePREADarunavir - PrezistaJanssen Products, L.P.NoneClinical pharmacology (PDF - 352 KB)NonePREADarunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Symtuza Janssen Products, L.P.Multi-disciplinary review (PDF - 8 MB)NoneNone PREA Dasatinib - Sprycel Bristol-Myers Squibb Company CDTL Review (PDF - 1 MB) Medical (PDF - 8 MB) Clinical pharmacology (PDF - 531 KB)Statistical (PDF - 19 KB)BPCA Dasiglucagon - Zegalogue Zealand Pharma A/SMedical (PDF - 5 MB) Clinical pharmacology (PDF - 33 KB) Clinical pharmacology Addendum (PDF - 38 KB) Statistical (PDF - 2 MB)PREADaunorubicin and cytarabine (liposome injection) - Vyxeos Jazz PharmaceuticalsMultidisciplinary (PDF - 5 MB)NoneNoneBPCADecitabine - Dacogen Eisai Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)NoneBPCADeferasirox - ExjadeNovartis Pharmaceuticals CorporationMedical (PDF - 9 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)BPCADeferasirox - ExjadeNovartis Pharmaceuticals Corporation CDTL Review (PDF - 795 K/media-base/189962B) Medical (PDF - 843 KB) NoneNoneBPCADeferasirox - JadenuNovartis Pharmaceuticals Corporation CDTL Review (PDF - 2 MB) Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB)NoneBPCADenosumab-bmwo - OsenveltCelltrion, Inc.Medical (PDF - 9 MB)NoneNonePREADenosumab-bmwo - StobocloCelltrion, Inc.CDTL (PDF - 2 MB)NoneNonePREADenosumab-bnht - ConexxenceFresenius Kabi USA, LLC Medical (PDF - 1 MB) Medical (PDF - 1 MB) NoneNonePREADenosumab-dssb - Ospomyv Samsung Bioepis Co., Ltd.Medical (PDF - 212 KB)NoneNonePREADenosumab-kyqq - BosayaBiocon Biologics Inc.Medical (PDF - 4 MB)NoneNonePREADenosumab-nxxp - BildyosShanghai Henlius Biotech, IncMedical (PDF - 4 MB)NoneNonePREADenosumab - ProliaAmgen Inc.Medical (PDF - 2 MB)NoneNone PREADesoximetasone - TopicortTaro Pharmaceuticals U.S.A., Inc.Medical (PDF - 221 KB)Clinical pharmacology (PDF - 302 KB)NonePREADesvenlafaxine - PristiqWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. Medical (PDF - 103 KB) Medical (PDF - 622 KB) Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)PREADeutetrabenazine - Austedo Teva Branded Pharmaceutical Products R&D, Inc.Medical (PDF - 622 KB)NoneNoneBPCADexamethasone ophthalmic insert - DEXTENZAOcular Therapeutix, Inc.Medical (PDF - 1 MB)NoneStatistical (PDF - 2 MB)PREADexlansoprazole - DexilantTakeda Pharmaceuticals USA Inc.CDTL Review (PDF - 661 KB) Medical (PDF- 5 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 50 KB)PREADexmedtomidine hydrochloride - PrecedexHospiraMedical (PDF - 5 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF -1 MB)BPCADexmedetomidine - PrecedexHospira, Inc.CDTL Review (PDF - 3 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 1 MB)PREADextroamphetamine - XelstrymNoven Pharmaceuticals, Inc.Medical (PDF - 1 MB) NoneNonePREADiclofenac epolamine topical system 1.3% - Flector IBSA Institut Biochimique SAMedical (PDF - 1 MB) NoneNonePREADiclofenac potassium - Zipsor Assertio Therapeutics, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 453 KB)NonePREADifluprednate ophthalmic emulsion - DurezolAlcon Pharmaceuticals Ltd. c/o Alcon Research LtdMedical (PDF -748 KB)Clinical pharmacology (PDF - 40 KB)Statistical (PDF - 479 KB)BPCADolutegravir and lamivudine - DovatoViiV Healthcare CompanyMedical (PDF - 2 MB)NoneNonePREADolutegravir - TivicayViiV HealthcareMedical (PDF - 8 MB)Clinical pharmacology (PDF - 11 MB)Statistical (PDF - 4 MB)PREADolutegravir - Tivicay ViiV HealthcareMedical (PDF - 2 MB) CDTL Review (PDF - 932 KB)Clinical pharmacology (PDF - 2 MB)NonePREADolutegravir - Tivicay PD ViiV HealthcareMedical (PDF - 241 KB)Clinical pharmacology (PDF - 89 KB)NonePREADoravirine/lamivudine/tenofovir disoproxil fumarate - Delstrigo Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.CDTL Review (PDF - 962 KB)Clinical pharmacology (PDF - 2 MB)NonePREADordaviprone - ModeysoChimerix, Inc.Medical (PDF - 1 MB)NoneNonePREADoxercalciferol - HectorolGenzyme CorporationMedical (PDF - 4 MB)NoneNonePREADoxycycline hyclate delayed-release - DoryxMayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLCMedical (PDF - 241 KB)Clinical pharmacology (PDF - 89 KB)Statistical (PDF - 131 KB)PREADoxycycline hyclate - LymePakChartwell Pharma NDA B2 Holdings, LLCMedical (PDF - 1 MB)NoneNonePREADrospirenone and estetrol tablets - Nextstellis Mayne Pharma LLCMedical (PDF - 3 MB)NoneNonePREADrospirenone - SlyndExeltis USA, IncMedical (PDF - 1 MB)NoneNonePREADulaglutide - TrulicityEli Lilly and CompanyCDTL (PDF - 1 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 2 MB)BOTHDuloxetine - CymbaltaEli Lilly and Company, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 197 KB)Statistical (PDF - 3 MB)PREADuloxetine - Cymbalta Eli Lily and Company, Inc.Medical (PDF - 2 MB)NoneNonePREADuloxetine delayed-release capsules - Drizalma Sprinkle Sun Pharma Global FZEMedical (PDF - 2 MB)NoneNonePREADuloxetine hydrochloride - CymbaltaEli Lilly and CompanyMedical (PDF - 8 MB)Clinical pharmacology (PDF - 959 KB)Statistical (PDF - 665 KB)BPCADupilumab - DupixentRegeneron Pharmaceuticals, Inc.Medical (PDF - 8 MB)NoneNonePREADupilumab - DupixentRegeneron Pharmaceuticals, Inc.Medical (PDF - 8 MB)NoneNonePREADupilumab - DupixentRegeneron Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNonePREADupilumab - DupixentRegeneron Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNonePREADupilumab - DupixentRegeneron Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNonePREADupilumab - DupixentRegeneron Pharmaceuticals, Inc.Medical (PDF - 14 MB)NoneNonePREAEconazole nitrate - Ecoza AmDerma Pharmaceuticals, LLCMedical (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 422 KB)PREAEculizumab-aagh - EpysqliSamsung Bioepis Co., Ltd.Medical (PDF - 518 KB)NoneNonePREAEdoxaban - SavaysaDaiichi Sankyo, Inc. CDTL (PDF - 4 MB) Medical (PDF - 4 MB) Clinical pharmacology (PDF - 1 MB)NonePREAEfavirenz, lamivudine, tenofovir - Symfi Lo Mylan Pharmaceuticals, Inc.Medical (PDF - 129 KB)Clinical pharmacology (PDF - 1 MB)NonePREAEfavirenz, lamivudine, tenofovir Disoproxil Fumarate - Symfi Mylan Pharmaceuticals, Inc.Medical (541 - KB)NoneNonePREAEfavirenz, Lamivudine and Tenofovir disoproxil fumarateAurobindo Pharma Limited, IndiaDD Review (PDF - 65 KB)Clinical pharmacology (PDF - 788 KB)NonePREA Efavirenz, lamivudine, tenofovir disoproxil fumarate Macleods Pharmaceuticals Limited, IndiaMedical (PDF - 2 MB)Clinical pharmacology (PDF - 788 KB)NonePREAEfavirenz - SustivaBristol-Myers Squibb CompanyMedical (PDF - 2 MB)Clinical pharmacology (PDF - 9 MB)NoneBOTHEfinaconazole - JubliaBausch Health Americas, Inc.Medical (PDF - 538 KB)NoneNonePREAElbasvir and grazoprevir - ZepatierMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NonePREAEltrombopag - AlvaizTeva Pharmaceuticals Inc. CDTL (PDF - 2 MB) Medical (PDF - 583 MB) Clinical pharmacology (PDF - 975 MB)NonePREAEltrombopag - Promacta Novartis Pharmaceuticals CorporationMedical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)BPCAEltrombopag - Promacta Novartis Pharmaceuticals CorporationMedical (PDF - 58 KB)NoneNone BPCAEltrombopag - PromactaNovartis Pharmaceuticals CorporationMedical (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 97 KB)BPCAElvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - GenvoyaGilead Sciences, Inc.Medical (PDF - 13 MB)Clinical pharmacology (PDF - 24 MB)Statistical (PDF - 2 MB)PREAElvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - GenvoyaGilead Sciences, Inc.Medical (PDF - 642 KB)Clinical pharmacology (PDF - 242 KB)NoneBOTHElvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - GenvoyaGilead Sciences, Inc.CDTL (PDF - 3 MB)Clinical pharmacology (PDF - 9 MB)NoneBPCAElvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - StribildGilead Sciences, Inc.CTDL Review (PDF - 359 KB)Clinical pharmacology (PDF - 462KB)NonePREAEmpagliflozin - JardianceBoehringer Ingelheim Pharmaceuticals, Inc.Medical - CDTL (PDF - 7 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)BPCAEmpagliflozin and Metformin - SynjardyBoehringer Ingelheim Pharmaceuticals, Inc.CDTL (PDF - 7 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 3 MB)BPCAEmpagliflozin and Metformin - Synjardy XRBoehringer Ingelheim Pharmaceuticals, Inc.CDTL (PDF - 7 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 3 MB)BPCAEmtricitabine and tenofovir alafenamide - DescovyGilead Sciences, Inc.CDTL (PDF - 7 MB)NoneNonePREAEmtricitabine, Rilpivirine, and Tenofovir alafenamide - OdefseyGilead Sciences, Inc.Medical (PDF 264 KB)NoneNonePREAEmtricitabine, Rilpivirine, and Tenofovir alafenamide - OdefseyGilead Sciences, Inc.Medical (PDF - 310 KB) CTDL Review (PDF - 578 KB)Clinical pharmacology (PDF - 5 MB) Clinical pharmacology addendum (PDF - 297 KB)NonePREAEmtricitabine, Rilpivirine, and Tenofovir alafenamide - DescovyGilead Sciences, Inc.Medical (PDF - 1 MB) Addendum (PDF - 572 KB)Clinical pharmacology (PDF - 8 MB)Statistical (PDF - 2 MB)PREAEmtricitabine, Rilpivirine, and Tenofovir alafenamide - DescovyGilead Sciences, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 8 MB)Statistical (PDF - 2 MB)PREAEmtricitabine and tenofovir alafenamide - DescovyGilead Sciences, Inc.Medical (PDF - 642 KB)Clinical pharmacology (PDF - 145 KB)NonePREAEmtricitabine and tenofovir alafenamide - DescovyGilead Sciences, Inc.CDTL Review (PDF - 2 MB)NoneNonePREAEmtricitabine and tenofovir alafenamide - DescovyGilead Sciences, Inc.Medical (PDF - 13 MB)NoneNonePREAEmtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - CompleraGilead Sciences, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF -145 KB)NonePREAEmtricitabine and Tenofovir disoproxil fumarate - Truvada Gilead Sciences, Inc.Medical (PDF - 501 KB)Clinical pharmacology (PDF -189 KB)NonePREAEntecavir - BaracludeBristol-Myers Squibb CompanyMedical (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 660 KB)BOTHEntrectinib - Rozlytrek GenentechMedical (PDF - 23 MB)NoneNoneBPCAEntrectinib - RozlytrekGenentech, Inc.Medical (PDF - 14 MB) NoneNoneBPCAErlotinib - TarcevaOSI Pharmaceuticals, LLCMedical (PDF - 6 MB)Clinical pharmacology (PDF - 2 MB)NoneBPCAEribulin mesylate - HalavenEisai Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)NoneBPCAEpinephrine - Auvi-QKaleo, Inc.Medical (PDF - 2 MB)NoneNonePREAEpinephrine - NeffyARS Pharmaceuticals Operations, Inc.Medical (PDF - 17 MB)NoneNonePREAEpinephrine - Primatene MistArmstrong Pharmaceuticals, Inc. CDTL Review (PDF - 2 MB) Medical (PDF - 4 MB) NoneStatistical (PDF - 660 KB)PREAEpinephrine nasal spray - NeffyARS Pharmaceuticals Operations, Inc.Medical (PDF - 4 MB)NoneNonePREAEscitalopram oxalate - LexaproForest Laboratories, Inc.Medical (PDF - 218 KB)NoneNonePREAEscitalopram - LexaproAbbVie Inc.Medical (PDF - 6 MB)NoneNonePREAEslicarbazepine acetate - AptiomSunovion Pharmaceutical Inc.CDTL Review (PDF - 593 KB) Medical (PDF - 5 MB)Clinical pharmacology (PDF - 3 KB)NonePREAEszopiclone - LunestaSunovion Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF -883KB)NoneBOTHEtafilcon - Theravision with KetotifenJohnson & Johnson Vision Care, Inc. DD Review (PDF - 2 MB) Medical (PDF - 460 KB) NoneStatistical (PDF - 3 MB)PREAEtanercept - EnbrelImmunex Corporation, a wholly-owned subsidiary of Amgen Inc. Medical (PDF - 5 MB) DD Review (PDF - 568 KB) CDTL Review PDF - 504 KB) Clinical pharmacology (PDF - 702 KB)Statistical (PDF - 444 KB)PREAEtanercept - Enbrel Amgen Inc.Medical (PDF - 4 MB)NoneNonePREAEtanercept-szzs - ErelziSandoz Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 432 KB)PREAEtanercept-szzs - Erelzi Sandoz Inc.CDTL Review PDF - 504 KB)NoneNonePREAEtanercept-szzs - Erelzi Sandoz Inc.Medical (PDF - 2 MB)NoneNonePREAEtravirine - IntelenceJanssen Products, LPMedical (PDF - 1 MB)Clinical pharmacology (PDF - 7 MB)NoneBOTHEtravirine - IntelenceJanssen Products, LPMedical (PDF - 1 MB)Clinical pharmacology (PDF - 896 KB)NoneBOTHEverolimus tablets for oral suspension - Afinitor DisperzNovartis Pharmaceuticals CorporationMedical (PDF - 10 MB)Clinical pharmacology (PDF - 2 MB)NoneBPCAEvolocumab - Repatha Amgen, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)PREAExenatide - BydureonAstraZeneca Pharmaceuticals AB C/O AstraZeneca Pharmaceuticals LPMedical (PDF - 3 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 1 MB)BOTHExenatide - ByettaAstraZeneca ABMedical (PDF - 802 KB)Clinical pharmacology (PDF - 14 KB)Statistical (PDF - 122 KB)BOTHFenfluramine HCl - Fintepla Zogenix, Inc.Medical (PDF - 588 KB)Clinical pharmacology (PDF - 2 MB)NoneBPCAFerric oxyhydroxide - VelphoroVifor Fresenius Medical Care Renal Pharma FranceMedical (PDF - 1 MB)NoneNoneBPCAFerric carboxymaltose -InjectaferAmerican Regent, Inc.Medical (PDF - 613 KB)Clinical pharmacology (PDF - 7 MB)NonePREAFesoterodine fumarate - ToviazPfizer, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 6 MB)Statistical (PDF - 300 KB)BOTHFidaxomicin - Dificid Cubist Pharmaceuticals LLCMedical (PDF - 4 MB)NoneNoneBPCAFilgrastim-ayow - ReleukoKashiv BioSciences, LLCMedical (PDF - 4 MB)NoneNonePREAFilgrastim-sndz - ZarxioSandoz, Inc.Medical (PDF - 4 MB) DD Review (PDF - 86 KB) TL Review (PDF - 422 KB)Clinical pharmacology (PDF - 3 MB) Addendum (PDF - 1 MB)Statistical (PDF - 6 MB)PREAFilgrastim-aafi - Nivestym Hospira, Inc. CDTL Review (PDF - 746 KB) Medical (PDF - 245 KB) Clinical pharmacology (PDF - 661 KB)Statistical (PDF - 377 KB)PREA Filgrastim-sndz - ZarxioSandoz Inc.CDTL (PDF - 861 KB)NoneNonePREAFinafloxacin otic suspension - XtoroAlcon Research, Ltd.Medical (PDF - 7 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 3 MB)BOTHFingolimod - Gilenya Novartis Pharmaceuticals Corporation CDTL Review (PDF - 2 MB) Medical (PDF - 4 MB) Clinical pharmacology (PDF - 2 MB)Statistical (PDF -3 MB)BOTHFingolimod - Tascenso ODTHanda Neuroscience, LLC Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB) NonePREAFluticasone furoate inhalation powder - Arnuity ElliptaGlaxoSmithKlineMedical (PDF - 9 MB)Clinical pharmacology (PDF - 6 MB)Statistical (PDF - 2 MB)PREAFluticasone furoate - Arnuity ElliptaGlaxoSmithKlineMedical (PDF - 956 KB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 507 KB)PREA Fluticasone furoate - Arnuity ElliptaGlaxoSmithKline Intellectual Property Development Ltd. EnglandMedical (PDF - 956 KB)NoneNonePREAFluticasone furoate - Flonase Sensimist Allergy ReliefHaleon US HoldingsMedical (PDF - 489 KB)NoneStatistical (PDF - 133 KB)PREAFluticasone Furoate/Umeclidinium/Vilanterol - Trelegy ElliptaGlaxoSmithKline Intellectual Property Development Ltd. EnglandMedical (PDF - 3 MB)NoneNonePREAFluticasone furoate/vilanterol - Breo Ellipta GlaxoSmithKlineMedical (PDF - 16 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 4 MB)PREAFluticasone furoate and vilanterol - Breo ElliptaGlaxoSmithKline Intellectual Property Development Ltd. England C/o GlaxoSmithKline Research & DevelopmentMedical (PDF - 6 MB)NoneNoneBPCAFluticasone propionate Lotion - CutivateFougera Pharmaceuticals Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NonePREAFluticasone propionate/salmeterol xinafoate - Advair HFAGlaxoSmithKlineMedical (PDF -1 MB)Clinical pharmacology (PDF - 267KB)Statistical (PDF - 52 KB)PREAFluticasone propionate - ArmonAir RespiClickTeva Pharmaceutical Industries Ltd.Medical (PDF - 10 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 1 KB)PREAFluticasone propionate - ArmonAir RespiClickTeva Pharmaceutical Industries Ltd. c/o: Teva Branded Pharmaceutical Products R&D Inc.Medical (PDF - 6 MB)NoneNoneBOTHFluticasone propionate/salmeterol - AirDuoTeva Pharmaceutical Industries Ltd.Medical (PDF -10 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 1 KB)PREAFondaparinux sodium - ArixtraMylan Ireland LimitedMedical (PDF - 2 MB)NoneNonePREAFormoterol fumarate and mometasone furoate - DuleraMerck Sharp & Dohme Corp.Medical (PDF - 10 MB)NoneNoneBOTHFosaprepitant - Emend Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 7 MB)Statistical (PDF - 662 KB)BOTHFosaprepitant - Focinvez Spes Pharmaceuticals Inc. Unireview (PDF - 248 MB) Unireview (PDF - 1 MB) NoneNonePREAFosphenytoin sodium - CerebyxParke-Davis, a Division of Pfizer, Inc.CDTL Review (PDF - 390 KB) Medical (PDF - 2 MB)Clinical pharmacology (PDF - 5 MB)NoneBPCAFremanezumab - AjovyTeva Pharmaceuticals USA, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)PREAGadobutrol - GadavistBayer HealthCare Pharmaceuticals, Inc.Medical (PDF - 958 KB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 422 KB)PREAGadobutrol - GadavistBayer Healthcare Pharmaceuticals, Inc.Medical (PDF - 7 MB)NoneStatistical (PDF - 782 KB)PREAGadopiclenol - EluciremGuerbet LLCMedical (PDF - 3 MB)NoneNonePREAGadoterate meglumine - DotaremGuerbet LLCMedical (PDF - 3 MB)Clinical pharmacology (PDF -768KB)Statistical (PDF - 1 MB)PREAGadoterate meglumine - DotaremGuerbet LLCMedical (PDF 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 398 KB)PREAGadoteridol - ProHanceBracco Diagnostics, IncMedical (PDF - 3 MB)NoneNonePREAGadoxetate disodium - Eovist Bayer HealthCare Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)NonePREAGatifloxacin ophthalmic solution - ZymarAllergan, Inc.Medical (PDF - 78 KB)NoneNoneBothGatifloxacin - Zymar Allergan, Inc.DDTL (PDF - 428 KB)NoneNoneBothGepirone - ExxuaFabre-Kramer Pharmaceuticals, Inc.Medical (PDF - 10 MB)NoneNoneBothGepotidacin - BlujepaGlaxoSmithKline, LLCMedical (PDF - 9)NoneNonePREAGlecaprevir and Pibrentasvir - Mavyret AbbVie Inc. CTDL (PDF - 2 MB) CTDL Addendum (PDF - 187 KB) Clinical pharmacology (PDF - 409 KB)Statistical (PDF - 439 KB)PREAGlecaprevir and Pibrentasvir - Mavyret AbbVie Inc.Medical (PDF - 78 KB)NoneNoneBOTHGlecaprevir and Pibrentasvir - MavyretAbbVie, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)NoneBOTHGlecaprevir and Pibrentasvir - MavyretAbbVie, Inc.Medical (PDF - 4 MB)NoneNonePREAGlucagon - Gvoke Xeris Pharmaceuticals, Inc.Medical (PDF - 3 MB) CTDL Review (PDF - 3 MBClinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)PREAGlucagon - Baqsimi Amphastar Pharmaceuticals, Inc.Medical (PDF - 4 MB)NoneNonePREAGlucagon - Baqsimi Eli Lilly and Company Medical (PDF - 3 MB) CTDL Review (PDF - 3 MBClinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)PREAGlycopyrronium - QbrexzaDermira, Inc.Medical (PDF - 6 MB) NoneNone PREA Golimumab - SimponiJanssen Biotech, Inc.Medical (PDF - 3 MB) Clinical pharmacology (PDF - 307 KB)Statistical (PDF - 1 MB)PREAGolimumab - Simponi Aria Janssen Biotech, Inc.Medical (PDF - 4 MB)NoneNonePREAGuanfacine - IntunivShireMedical (PDF - 2 MB) CTDL Review (PDF - 134 KB)Clinical pharmacology (PDF - 330 KB)Statistical (PDF - 544 KB)BothGuanfacine - IntunivShireMedical (PDF - 3 MB)Clinical pharmacology (PDF - 667 KB)Statistical (PDF - 3 MB)PREAGuselkumab - TremfyaJanssen Biotech, Inc.Medical (PDF - 3 MB)NoneNonePREAGuselkumab - TremfyaJanssen Biotech, Inc.Medical (PDF - 15 MB)NoneNone PREAHalobetasol - Propionate UltravateSun Pharmaceutical Industries, Inc.Medical (PDF - 150 KB)Clinical pharmacology (PDF - 303 KB)NonePREAHalobetasol Propionate - Lexette Mayne Pharma LLCMedical (PDF - 249 KB)Clinical pharmacology (PDF - 752 KB)NoneBOTHHydrochlorothiazide- INZIRQONovitium Pharma LLCCDTL (PDF - 1 MB)Clinical pharmacology (PDF - 3 MB)NonePREAIbrexafungerp - Brexafemme SCYNEXIS, Inc.Medical (PDF - 10 MB)NoneNonePREAIbrexafungerp - Brexafemme SCYNEXIS, Inc.Medical (PDF - 1 MB)NoneNonePREAIbrutinib - ImbruvicaPharmacyclics LLC Medical (PDF - 20 MB)NoneNoneBPCAIbuprofen - Caldolor Cumberland Pharmaceuticals, Inc.CTDL Review (PDF - 134 KB)Clinical pharmacology (PDF - 752 KB)NonePREAIbuprofen - CaldolorCumberland Pharmaceuticals, Inc.DD Summary Review (PDF - 669 KB) Medical (PDF - 3 MB) Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 378 KB)PREAImatinib - IMKELDIShorla Pharma LtdMedical (PDF - 785 KB)PREAIomeprol - IomervuBracco Diagnostics IncMedical (PDF - 2 MB)NoneNonePREAIncobotulinumtoxinA - Xeomin Merz Pharmaceuticals GmbHMedical (PDF - 2 MB)NoneStatistical (PDF - 1 MB)PREAincobotulinumtoxinA - XeominMerz Pharmaceuticals GmbHMedical (PDF - 1 MB)NoneStatistical (PDF - 872 KB)PREA Indocyanine green for Injection - Spy Agent Green Novadaq Technologies ULCMedical (PDF - 4 MB) NoneNonePREAInfliximab-axxq - AvsolaAmgen, Inc.Medical (PDF - 4 MB) NoneNonePREAInfliximab-dyyb - InflectraCelltrion, Inc.Medical (PDF - 5 MB) Addendum (PDF - 1 MB)NoneStatistical (PDF -2 MB)PREAInfliximab-abda - RenflexisSamsung Bioepsis Co., Ltd CDTL Review (PDF - 1 MB) Medical (PDF - 4 MB) Medical 2(PDF - 267 KB) Medical 3 (PDF - 93 KB) Clinical pharmacology (PDF - 8 MB) Statistical (PDF - 959 KB) Statistical 2 (PDF - 602 KB) PREAInsulin aspart injection - FiaspNovo Nordisk Inc. CDTL Review (PDF - 1 MB) Medical (PDF - 4 MB) Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 905 KB)PREAInsulin aspart-szjj - Merilog & Merilog - SoloStarSanofi-Aventis U.S. LLC CDTL Review (PDF - 250 KB) Medical (PDF - 4 MB) NoneNonePREAInsulin Degludec - TresibaNovo Nordisk Inc.CDTL Review (PDF - 7 MB) Medical (PDF - 7 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 905 KB)PREAInsulin Degludec / Insulin Aspart) - RyzodegNovo Nordisk Inc.Medical (PDF - 7 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 905 KB)PREAInsulin glargine-yfgn - SemgleeMylan Pharmaceuticals Inc.Medical (PDF - 8 MB)NoneNonePREAInsulin glargine-aglr - RezvoglarEli Lilly and CompanyMedical (PDF - 2 MB)NoneNonePREAInsulin lispro-aabc - Lyumjev Eli Lilly and CompanyMedical (PDF - 1 MB) Clinical pharmacology (PDF - 10 MB) Clinical pharmacology addendum (PDF - 10 KB) Statistical (PDF - 253 KB)PREAIodixanol - VisipaqueGE HealthCare Inc.CDTL Review (PDF - 2 MB) Medical (PDF - 2 MB)Clinical pharmacology (PDF - 988 KB)Statistical (PDF - 2 MB)PREAIohexol - OraltagInterpharma Praha, a.s.Medical (PDF - 91 KB)Clinical pharmacology (PDF - 294 KB)Statistical (PDF - 98 KB)PREAIopamidol - Isovue Bracco Diagnostics Inc.Medical (PDF - 2 MB)NoneNonePREAIpilimumab - Yervoy Bristol-Myers Squibb CompanyMedical (PDF 6 MB)Clinical pharmacology (PDF - 2 MB)NoneBPCAIpilimumab - YervoyBristol-Myers Squibb CompanyMedical (PDF 20 MB)NoneNoneBPCAIron Sucrose Injection, USP - VenoferLuitpold Pharmaceuticals, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 114 KB)Statistical (PDF - 576 KB)PREAIsavuconazonium sulfate - CresembaAstellas Pharma US Inc.Medical (PDF - 5 MB)NoneNoneBPCAIvabradine - Corlanor Amgen Inc. CDTL (PDF - 3 MB) Medical (PDF - 4 MB) Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 51 KB)BPCAIvacaftor - KalydecoVertex Pharmaceuticals IncorporatedMedical (PDF - 4 MB)NoneNoneBPCAIvacaftor - KalydecoVertex Pharmaceuticals Inc.Medical (PDF - 4 MB)NoneNoneBPCAIvacaftor and lumacaftor - OrkambiVertex Pharmaceuticals IncorporatedMedical (PDF - 1 MB)NoneNonePREAIxekizumab - TaltzEli Lilly and CompanyMedical (PDF - 2 MB)NoneNonePREAKit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol - TechnegasCyclomedica Australia Pty Ltd.Medical (PDF - 1 MB)NoneNonePREAKit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage Jubilant DraxImage, Inc Medical (PDF - 2 MB)NoneStatistical (PDF - 1 MB)PREALacosamide - Motpoly XRAucta Pharmaceuticals, Inc.Medical (PDF - 276 KB)Clinical pharmacology (PDF - 1 MB)NonePREALacosamide - Vimpat UCB, Inc. CDTL Review (PDF - 371 KB) Medical (PDF - 915 KB) Clinical pharmacology (PDF - 2 MB)NonePREALacosamide - Vimpat UCB, Inc. Medical (PDF - 541 KB) Medical (PDF - 631 KB) Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 2 MB)PREALacosamide - Vimpat UCB, Inc.Medical (PDF - 700 KB)Clinical pharmacology (PDF - 800 KB)NonePREALacosamide - VimpatUCB, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 9 MB)PREALactic acid citric acid and K bitartrate - PhexxiEvofem, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 KB)Statistical (PDF - 3 KB)PREALamivudine - EpivirViiV Healthcare CompanyMedical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)PREALamivudine and Raltegravir - DutrebisMerck Sharp & Dohme Corp.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 6 MB)NonePREALamivudine and tenofovir - Cimduo Mylan Pharmaceuticals IndiaMedical (PDF - 73 KMB)Clinical pharmacology (PDF - 1 MB)NonePREA Lamivudine and tenofovir disoproxil fumarate - Temixys Celltrion, Inc.Medical (PDF - 20 KB) Clinical pharmacology addendum (PDF - 166 KB) Clinical pharmacology (PDF - 1 MB) None PREALamotrigine - Lamictal GlaxoSmithKline LLCMedical (PDF - 18 MB)Clinical pharmacology (PDF - 793 KB)Statistical (PDF - 2 MB)PREALamotrigine - Subvenite NEWOWP Pharmaceuticals, Inc. CDTL 1 (PDF - 123 MB) CDTL 2 (PDF - 1 MB) Medical (PDF - 2 MB) Clinical pharmacology (PDF - 417 KB)NonePREALanadelumab-flyo - Takhzyro Takeda Pharmaceuticals U.S.A., Inc.Medical (PDF - 7 MB)NoneNoneBPCALebrikizumab-lbkz - EbglyssEli Lilly and Company Medical (PDF - 142 KB) Uniview (PDF - 10 MB) NoneNonePREALedipasvir-sofosbuvir - HarvoniGilead Sciences, Inc.Medical and CDTL (PDF - 2 MB)Clinical pharmacology (PDF - 539 KB)Statistical (PDF - 205 KB) PREALedipasvir-sofosbuvir - HarvoniGilead Sciences, Inc.Medical (PDF - 426 KB)NoneNoneBOTHLedipasvir-sofosbuvir - HarvoniGilead Sciences, Inc.CDTL (PDF - 31 KB)NoneNonePREALenacapavir - YeztugoGilead Sciences, Inc.Medical (PDF -12 MB)NoneNonePREALenvatinib - LenvimaEisai Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 1 MB)NoneBPCALeuprolide acetate - FensolviTolmar, Inc.Medical (PDF - 280 KB)Clinical pharmacology (PDF - 4 MBStatistical (PDF - 2 MB)PREALevalbuterol hydrochloride - XopenexOak PharmaceuticalsMedical (PDF - 8 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)PREALevalbuterol tartrate - Xopenex HFASunovion Pharmaceuticals Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF 1 MB)PREALevamlodipine - ConjupriCSPC Ouyi Pharmaceutical Co., Ltd.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 569 KB)NonePREALevetiracetam - Keppra Extended Release TabletsUCB, Inc.DD Summary Review (PDF - 202 KB) CDTL Review (PDF - 371 KB) Medical (PDF - 327 KB)Clinical pharmacology (PDF - 1 MB)NonePREALevetiracetam - Spritam Aprecia PharmaceuticalsMedical (PDF - 4 MB)NoneNonePREALevomilnacipran - FetzimaAbbVie Inc.Medical (PDF - 4 MB)NoneNonePREALevonorgestrel - LilettaMedicines360Medical (PDF - 9 MB)Clinical pharmacology (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)PREALevonorgestrel/ethinyl estradiol tablets - TyblumeExeltis CDTL (PDF - 9 MB) Medical (PDF - 9 MB) Medical (PDF - 9 MB) Clinical pharmacology (PDF - 1 MB) Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)PREALevonorgestrel/ethinyl estradiol and ethinyl estradiol - QuartetteTeva Branded Pharmaceutical Products R&D, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 4 MB) Clinical pharmacology addendum (PDF - 89 KB)Statistical (PDF - 1 MB)PREALevonorgestrel-releasing intrauterine system - SkylaBayer HealthCare Pharmaceuticals, Inc.Medical (PDF - 8 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 424 KB)PREALevonorgestrel releasing intrauterine system - LilettaMedicines360 CDTL Review (PDF - 179 KB) Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 168 KB)PREALevonorgestrel - MirenaBayer HealthCare Pharmaceuticals, Inc.Medical (PDF - 2 MB)NoneNonePREALevothyroxine sodium oral solution - Tirosint-SOLCromsource, Inc. CDTL Review (PDF - 461 KB) Medical (PDF - 3 MB) Clinical pharmacology (PDF - 2 MB)NonePREALinaclotide - LinzessAbbVie Inc.Medical (PDF - 3 MB)NoneNoneBOTHLinagliptin - TradjentaBoehringer Ingelheim Pharmaceuticals, IncMedical (PDF - 7 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)BOTHLipid injectable emulsion - SMOFlipid Fresenius Kabi USA, LLCMedical (PDF - 3 MB)Clinical pharmacology (PDF - 2 MB)NonePREALiraglutide - SaxendaNovo Nordisk, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 2 MB)PREALiraglutide - VictozaNovo Nordisk Inc.Medical (PDF - 8 MB)Clinical pharmacology (PDF - 864 KB)Statistical (PDF - 450 KB)BOTHLisdexamphetamine dimesylate - AryntaAzurity Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNonePREALisdexamfetamine dimesylate - Vyvanse Shire Development, LLCMedical (PDF - 218 KB)Clinical pharmacology (PDF - 1 MB)NonePREALisdexamfetamine dimesylate - VyvanseShireMedical (PDF - 2 MB)NoneStatistical (PDF - 1 MB)PREA Lisdexamfetamine dimesylate - Vyvanse Takeda Pharmaceuticals U.S.A., Inc.Medical (PDF - 804 KB)NoneNoneBOTHLisenatide - Adlyxin Sanofi-aventis U.S. LLCMedical (PDF - 182 KB)Clinical pharmacology (PDF - 1 MB)NoneBOTHLosartan potassium - ArbliScienture LLC Medical (PDF - 176 KB) CDTL1 (PDF - 707 KB) CDTL2 (PDF - 22 KB) Clinical pharmacology (PDF - 2 MB)PREALumacaftor and ivacaftor - Orkambi Vertex Pharmaceuticals IncorporatedMedical (PDF - 6 MB)NoneNoneBPCALoteprednol - Lotemax Bausch & Lonb Inc. Medical (PDF - 318 KB) Medical (PDF - 218 KB) NoneStatistical (PDF - 3 MB)PREALuliconazole - LuzuTMMedicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC CDTL (PDF - 358 KB) CDTL (PDF - 372 KB) Medical (PDF - 306 KB) Medical (PDF - 616 KB) Clinical pharmacology (PDF - 1 MB) Clinical pharmacology (PDF - 423 KB) Statistical (PDF - 207 KB) PREALopinavir / Ritonavir - KaletraAbbVie Inc.Medical (PDF - 6 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)PREALubiprostone - AmitiziaSucampo Pharmaceuticals Inc.Medical (PDF - 11 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)PREALutetium Lu177 dotatate - LutatheraAdvanced Accelerator Applications USA, Inc.Medical (PDF - 3 MB)NoneNoneBPCALurasidone hydrochloride - LatudaSunovion Pharmaceuticals, Inc. Medical (PDF - 6 MB) Medical (PDF - 7 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 369 KB) Statistical (PDF - 255 KB) BOTHLurasidone hydrochloride - LatudaSunovion Pharmaceuticals, Inc. CDTL (PDF - 6 MB) Medical (PDF - 6 MB) Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 368 KB)PREALurasidone hydrochloride - LatudaSunovion Pharmaceuticals, Inc.Medical (PDF - 1 MB)NoneNonePREAMacitentan - Opsumit Actelion Pharmaceuticals US, Inc.Medical (PDF - 14 MB)NoneNoneBPCAMaraviroc - SelzentryViiv HealthcareMedical (PDF - 1 MB)Clinical pharmacology (PDF - 3 MB)NonePREAMaraviroc - SelzentryViiv HealthcareMedical (PDF - 1 MB)Clinical pharmacology (PDF - 3 MB)NoneBPCAMemantine hydrochloride - Namenda XRForest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.)Medical (PDF - 2 MB)Clinical pharmacology (PDF - 956 KB)Statistical (PDF - 1 MB)BPCAMepolizumab - NucalaGlaxoSmithKline LLCMedical (PDF - 8 MB)Clinical pharmacology (PDF - 6 MB) Clinical pharmacology addendum (PDF - 425 KB)Statistical (PDF - 1 MB)PREAMepolizumab - NucalaGlaxoSmithKline LLCMedical(PDF - 8 MB)NoneNonePREAMepolizumab - NucalaGlaxoSmithKline LLCMedical (PDF - 8 MB)NoneNonePREAMirabegron - Myrbetriq Astellas Pharma Global Development, Inc.Medical (PDF - 13 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 168 KB)BOTHMesalamine - Asacol HDWarner ChilcottMedical (PDF - 6 MB)Clinical pharmacology (PDF - 3 MB) Clinical pharmacology (PDF - 518 KB)Statistical (PDF - 499 KB)PREAMesalamine - CanasaForest LaboratoriesMedical (PDF - 6 MB)Clinical pharmacology (PDF - 251 KB)Statistical (PDF - 344 KB)PREAMesalamine - DelzicolWarner Chilcott LLCMedical (PDF - 707 KB) Medical Addendum(PDF - 495 KB)Clinical pharmacology (PDF - 116 KB)NonePREAMesalamine - Delzicol Warner Chilcott (US), LLCMedical (PDF - 5 MB)Clinical pharmacology (PDF - 729 KB)Statistical (PDF - 1 KB)PREAMesalamine - Lialda Shire Development, LLCMedical (PDF - 6 MB)NoneNonePREAMetformin hydrochloride for extended-release oral suspension - Riomet ERPharmaceutical Industries LimitedCTDL Review (PDF - 917 KB)Clinical pharmacology (PDF - 818 KB)NonePREA10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief Hisamitsu Pharmaceutical Co., Inc.Medical (PDF - 998 KB) Medical (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREAMethylphenidate hydrochloride extended-release - Aptensio XRRhodes Pharmaceuticals L.P.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 1 MB) Statistical (PDF - 629 KB)PREAMethylphenidate hydrochloride - Aptensio XRRhodes Pharmaceuticals L.P.CTDL Review (PDF - 592 KB) Medical (PDF - 3 MB)Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 1 MB) Statistical (PDF - 139 KB) BOTHMethylphenidate hydrochloride - Quillivant XRNextWave Pharmaceuticals, Inc.Medical (PDF - 26 KB)Clinical pharmacology (PDF - 588 KB)Statistical (PDF - 380 KB)PREAMethylphenidate hydrochloride extended release chewable tablets - QuilliChew ER Pfizer Inc.CTDL Review (PDF -1 MB) Medical (PDF - 5 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 498 KB)PREAMethylphenidate HCL extended-release capsules - Adhansia XR Purdue Pharma Medical (PDF - 2 MB) Medical (PDF - 5 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 1 MB) Statistical (PDF - 2 MB) PREA Methylphenidate hydrochloride - Jornay PM Ironshore Pharmaceuticals & Development, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 921 KB)PREAMethylphenidate extended-release orally disintegrating tablets - Cotempla XR-ODT Neos Therapeutics, Inc. Medical (PDF - 6 MB) Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 2 MB) Statistical (PDF - 921 KB) Statistical (PDF - 96 KB) PREAMethoxy polyethylene glycol-epoetin beta - MirceraVifor International AGMedical (PDF - 2 MB)NoneStatistical (PDF - 239 KB)PREAMethoxy polyethylene glycol-epoetin beta - MirceraVifor (International) AG c/o ProPharma GroupMedical (PDF - 7 MB)Clinical Pharmacology (PDF - 5 MB)Statistical (PDF - 7 MB)PREAMetoprolol Succinate - KAPSPARGO SPRINKLESun Sun Pharmaceutical Industries LimitedPharmaceutical Industries LimitedMedical (PDF - 799 KB)Clinical pharmacology (PDF - 978 KB)NonePREAMetronidazole - LikmezSaptalis Pharmaceuticals, LLCMedical (PDF - 6 MB)NoneNonePREAMetronidazole vaginal gel 1.3% - NuvessaChemo Research SLMedical (PDF - 1 MB)Clinical pharmacology (PDF - 70 KB)Statistical (PDF - 127 KB)PREA Micafungin for Injection - MycamineAstellas Pharma US, Inc.Medical (PDF - 1 MB)NoneNoneBOTHMicafungin in Sodium Chloride InjectionBaxter HealthCare CorporationMedical (PDF - 1 MB)NoneNonePREAMicafungin sodium - MycamineAstellas Pharma US, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 987 KB)BPCAMinocycline - Amzeeq Foamix Pharmaceuticals Inc.Medical (PDF - 2 MB)NoneNonePREAMirabegron extended-release tablets and mirabegron extended-release for oral suspension - Myrbetriq and Myrbetriq GranulesAstellas Pharma Global Development, Inc.Medical (PDF - 13 MB)NoneNoneBOTHMixed salts of a single-entity amphetamine product - Mydayis Shire Development, LLC.Medical (PDF - 7 MB)Clinical pharmacology (PDF - 2 KB)Statistical (PDF - 987 KB)PREAMixed salts of a single entity amphetamine product - Mydayis Shire Development, LLC.Medical (PDF - 7 MB)NoneNoneBPCAMometasone furoate - Asmanex HFAMerck Sharp & Dohme Corp.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 603 KB)PREAMometasone furoate - Asmanex HFAMerck Sharp & Dohm CorpMedical (PDF- 1 MB)NoneNonePREAMometasone furoate - Asmanex HFAMerck Sharp & Dohm CorpMedical (PDF - 1 MB)NoneNonePREAMometasone furoate and formoterol fumarate - DuleraSchering-PloughMedical (PDF- 1 MB)NoneNonePREAMorphine sulfate - Morphine sulfateHospira, Inc.Medical (PDF - 1 MB)NoneNonePREAMorphine sulfate - Morphine sulfateHikma Pharmaceuticals USA Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 3 MB)NonePREAMoxifloxacin - AveloxBayer PharmaceuticalsMedical (PDF- 905 KB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 760 KB)PREAMoxifloxacin ophthalmic solution - VigamoxAlcon Pharmaceuticals, Ltd.Medical (PDF - 434 KB) DD Summary Review (PDF- 118 KB)NoneNoneBPCAMycophenolate mofetil - CellCept Roche Palo Alto LLCMedical (PDF - 6 MB)NoneNonePREAMycophenolate mofetil oral suspension - MyhibbinLiqmeds Worldwide Limited Unireview (PDF - 10 MB) Medical (PDF - 353 KB) NoneNonePREANaftifine hydrochloride - NaftinMerz Pharmaceuticals, LLCMedical (PDF - 488 KB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 188 KB)PREANaftifine hydrochloride - Naftin Cream, 2%Merz Pharmaceuticals, LLCMedical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 822 KB) PREANalmefene - OpveeOpiant Pharmaceuticals, Inc. CTDL Review (PDF - 4 MB) Medical (PDF - 1 MB) Clinical pharmacology (PDF - 9 MB) Clinical pharmacology addendum (PDF - 9 KB) Statistical (PDF - 2 MB)PREANalmefene injection - ZurnaiPurdue Pharma, L.P. CDTL-DD (PDF - 2 MB) Medical (PDF - 3 MB) Clinical pharmacology (PDF - 5 MB)NonePREA Naloxone hydrochloride - Kloxxado Hikma Pharmaceuticals USA, Inc. CTDL Review (PDF - 613 KB) CTDL and DD Review (PDF - 1 MB) Medical (PDF - 4 MB) NoneNonePREA Naloxone hydrochloride - Kloxxado Hikma Pharmaceuticals USA, Inc.CTDL Review (PDF - 359 KB)Clinical pharmacology (PDF - 2 MB)NonePREANaloxone hydrochloride - Narcan Nasal Spray Adapt Pharma Operations LimitedDD Summary Review(PDF -1 MB) CTDL Review (PDF - 3 MB)Clinical pharmacology (PDF - 2 MB)NonePREANaloxone Hydrochloride Injection - Naloxone Hydrochloride InjectionKaleo, Inc.CDTL Review (PDF - 2 MB)Clinical pharmacology (PDF - 4 MB)NonePREANaloxone Hydrochloride - RextovyAmphastar Pharmaceuticals, Inc Medical (PDF - 3 MB) CDDD Review (PDF - 637 KB) Clinical pharmacology (PDF - 2 MB)NonePREANaloxone Hydrochloride - RezenopySummit Biosciences Medical (PDF - 2 MB) CDTL Review (PDF - 3 MB) Clinical pharmacology (PDF - 1 MB)NonePREANaloxone hydrochloride - RiViveHarm Reduction Therapeutics, Inc.Medical (PDF - 2 MB)NoneNonePREANaloxone hydrochloride - ZimhiAdamis Pharmaceuticals CorporationCDTL Review (PDF - 2 MB)Clinical pharmacology (PDF - 368 KB)NonePREANaproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PMBayer HealthCare, LLC – Consumer CareMedical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 1 MB)PREANaproxen and esomeprazole magnesium - Vimovo Horizon Pharma Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2 MB)NonePREANeostigmine methylsulfate - BloxiverzEclat Pharmaceuticals, LLCMedical (PDF - 8 MB)Clinical pharmacology (PDF - 2 MB)NonePREANeostigmine methylsulfate and glycopyrrolate - PrevduoSlayback Pharma LLCCDTL Review (PDF - 794 KB)Clinical pharmacology (PDF - 284 KB)NonePREANevirapine - Viramune XRBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 446 KB)Statistical (PDF - 723 KB)PREANilotinib - Tasigna Novartis Pharmaceuticals CorporationMedical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 124 KB)BPCANintedanib - OfevBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 10 MB)NoneNoneBPCANintedanib - OfevBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 249 KB)NoneNoneBCPANirmatrelvir - Ritonavir - PaxlovidPfizer, IncMedical (PDF - 27 MB)NoneNonePREANirsevimab-alip - BeyfortusAstraZeneca ABMedical (PDF - 20 MB)NoneNonePREANirsevimab-alip - BeyfortusAstraZeneca ABMedical (PDF - 2 MB)NoneNonePREANitisinone - NITYRCycle Pharmaceuticals Ltd.Medical (PDF - 358 KB)Clinical pharmacology (PDF - 4 MB)NonePREANitisinone - NITYRCycle Pharmaceuticals Ltd.Medical (PDF - 358 KB)NoneNonePREANivolumab - Opdivo Bristol-Myers Squibb Company DD (PDF - 188 KB) Medical (PDF - 222 KB) Clinical pharmacology (PDF - 202 KB) Clinical pharmacology (PDF - 250 KB) NonePREANivolumab - OpdivoBristol-Myers Squibb CompanyMedical (PDF - 8 MB)NoneNoneBPCANivolumab - OpdivoBristol-Myers Squibb CompanyMedical (PDF - 11 MB)NoneNoneBPCANivolumab - OpdivoBristol-Myers Squibb CompanyMedical (PDF - 17 MB)NoneNonePREANivolumab and relatlimab-rmbw - OpdualagBristol-Myers Squibb CompanyMedical (PDF - 29 MB)NoneNonePREANorethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Taytulla Warner Chilcott Company, LLCMedical (PDF - 1 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 469 KB)PREANorethindrone acetate and ethinyl estradiol - FemlyvMillicent Puerto Rico LLCMedical (PDF - 1 MB)Clinical pharmacology (PDF - 3 MB)NonePREAObiltoxaximab - AnthimElusys Theraputics, Inc.Medical (PDF -18 MB) Addendum (PDF - 249 KB)Clinical pharmacology (PDF - 12 MB) Addendum (PDF - 126 KB)Statistical (PDF - 9 MB)PREAOcriplasmin- JetreaThromboGenics, Inc.Medical (PDF - 817 KB)Clinical pharmacology (PDF - 117 KB)Statistical (PDF - 760 KB) PREAOlanzapine and fluoxetine hydrochloride - SymbyaxEli Lilly and CompanyMedical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB) Addendum (PDF - 132 KB) Statistical (PDF - 953 KB)PREAOlopatadine - PazeoAlcon Research LTDMedical (PDF - 2 MB)Clinical pharmacology (PDF - 340 KB)Statistical (PDF - 4 KB)BOTHOlopatadine hydrochloride and mometasone furoate - RyaltrisGlenmark Specialty SA Medical (PDF - 6 MB) CDTL (PDF - 6 MB) NoneNonePREAOmalizumab - XolairGenentechMedical (PDF - 6 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 2 MB)PREAOmalizumab - XolairGenentech, Inc. and Novartis Pharmaceuticals Corp.Medical (PDF- 4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB) PREA Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp.Medical (PDF - 5 MB)NoneNone PREAOmalizumab - XolairGenentech, Inc.Medical (PDF - 8 MB)NoneNonePREAOmeprazole magnesium - Prilosec AstraZeneca Pharmaceuticals LPMedical (PDF - 908 KB)Clinical pharmacology (PDF - 2 MB)NonePREAOnabotulinumtoxinA - BotoxAllergan, Inc. CDTL (PDF - 403 KB) Medical (PDF - 1 MB) NoneStatistical (PDF - 173 KB)PREA OnabotulinumtoxinA - BotoxAllergen, Inc Medical (PDF - 3 MB) Medical (PDF - 1 MB) NoneStatistical (PDF - 1 MB)PREAOnabotulinumtoxinA - Botox Allergen, IncMedical (PDF - 1 MB)NoneNonePREAOnabotulinumtoxinA - Botox Allergan, Inc.Medical (PDF - 1 MB)NoneStatistical (PDF - 2 MB)PREAOnabotulinumtoxinA - Botox Allergan, Inc.Medical (PDF - 3 MB)NoneNonePREAOxaprozin - CoxantoSolubiomix, Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 2 MB)NonePREAOxcarbazepine - Oxtellar XRSupernus Pharmaceuticals, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 7 MB)Statistical (PDF - 482 KB)PREAOxycodone hydrochloride - Oxycodone hydrochlorideGenus Lifesciences, Inc. Medical (PDF - 2 MB) DD Memo (PDF - 1 MB) Clinical pharmacology (PDF - 688 KB)NonePREAOxycodone hydrochloride - OxycontinPurdue Pharma L.P.Medical (PDF - 17 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 678 KB)BPCAOxymorphone - OpanaMedical (PDF - 17 MB)Clinical pharmacology (PDF - 2 MB)NonePREAOzenoxacin - Xepi Ferrer Internacional S.A.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 524 KB)PREAPaclitaxel - AbraxaneAbraxis BioScience, L.L.C., a wholly-owned subsidiary of Celgene CorporationMedical (PDF - 235 KB)NoneNoneBPCAPalbocilib - IbrancePfizer Inc.CDTL - DD (PDF - 161 KB)Clinical pharmacology (PDF - 232 KB)NoneBPCAPalifermin - KepivanceQuintiles, Inc.Medical (PDF - 280 KB)Clinical pharmacology (PDF - 726 KB)NonePREAPalonosetron hydrochloride - AloxiHelsinn Healthcare SAMedical (PDF - 15 MB) Medical (PDF - 2 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 771 KB)BOTHPancrelipase - CreonAbbVie Inc.Medical (PDF - 566 KB)NoneNonePREAPancrelipase - Pancreaze Janssen Pharmaceuticals, Inc.Medical (PDF - 142 KB)NoneNonePREAPancrelipase - PertzyeDigestive Care, Inc.Medical (PDF - 1 MB)NoneNonePREAPancrelipase - ZenpepAptalis Pharma Limited.Medical (PDF - 587 KB)NoneNonePREAPantoprazole sodium - Protonix IVWyeth Pharmaceuticals LLCMedical (PDF - 4 MB)NoneNonePREAParicalcitol - ZemplarAbbVie Inc.Medical (PDF - 3 MB) CDTL (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 427 KB)PREAPatiromer - VeltassaVifor Pharma, Inc.Medical (PDF - 3 MB)NoneNonePREAPegfilgrastim-cbqv - UDENYCA Coherus BioSciences, Inc Medical (PDF - 184 KB) Medical (PDF - 228 KB) CDTL (PDF - 584 KB) Clinical pharmacology (PDF - 968 KB)Statistical (PDF - 199 KB)PREA Pegfilgrastim-fpgk - StimufendFresenius Kabi USA, LLCCDTL (PDF - 198 KB)NoneNonePREAPegfilgrastim-bmez - ZiextenzoSandoz Inc.CDTL (PDF - 348 KB)NoneNonePREAPegfilgrastim-pbbk - FylnetraKashiv BioSciences, LLCCDTL (PDF - 30 KB)NoneNonePREAPeginterferon alfa-2a - PegaysHoffmann-La Roche, IncorporatedMedical (PDF - 799 KB)Clinical pharmacology (PDF - 667 KB)Statistical (PDF - 667 KB)PREAPembrolizumab and berahyaluronidase alfa-pmph - Keytruda QlexMerck Sharp & Dohme LLCMedical (PDF - 15 MB)NoneNonePREAPeramivir - RapivabBioCryst Pharmaceuticals, Inc.Medical (PDF - 767 KBClinical pharmacology (PDF - 468 KB)Statistical (PDF - 767 KB)PREAPeramivir - Rapivab BioCryst Pharmaceuticals, Inc.Medical (PDF - 1 MBClinical pharmacology (PDF - 81 KB)NonePREAPerampanel - FycompaEisai, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 6 MB)Statistical (PDF -1 MB)PREAPerampanel - FycompaEisai, Inc.Medical (PDF - 3 MB) Medical (PDF - 2 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 1 MB)PREAPerampanel - FycompaEisai Inc.Medical (PDF - 3 MB) Medical MTL (PDF - 678 KB)Clinical pharmacology (PDF -1 MB)NonePREAPerampanel - FycompaEisai Inc.Medical (PDF - 79 KB)Clinical pharmacology (PDF - 86 KB)NonePREAPerampanel - FycompaEisai Inc. CDTL (PDF - 452 KB) Medical (PDF - 5 MB) Clinical pharmacology (PDF - 3 MB)NonePREA Perflutren lipid microsphere - DEFINITY and DEFINITY RT Lantheus Medical Imaging, Inc.Medical (PDF - 719 KB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 858 KB)PREAPentermine and topiramate - QsymiaVIVUS LLCMedical (PDF - 9 MB)Clinical pharmacology (PDF - 587 KB)Statistical (PDF - 858 KB)PREAPhentolamine mesylate - OraVerse Septodont Holding SasMedical (PDF - 3 MB)NoneStatistical (PDF - 1 MB)PREAPhenylephrine hydrochloride ophthalmic solutionParagon BioTeck, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 95 KB)Statistical (PDF -1 MB)PREAPhentolamine ophthalmic solution - RyzumviOcuphire Pharma, Inc. CDTL (PDF - 1 MB) Medical (PDF - 1 MB) Clinical pharmacology (PDF - 1 MB)NonePREAPhenylephrine and ketorolac - Omidria Omeros CorporationCDTL (PDF - 1 MB) Medical (PDF - 4 MB)NoneStatistical (PDF - 816 KB)BPCAPiperacillin and tazobactam - ZosynWyeth Pharmaceuticals LLCMedical (PDF - 2 MB)NoneNonePREAPitavastatin - LivaloKowa Pharmaceuticals America, Inc. CDTL Review (PDF - 526 KB) Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 240 KB)BPCAPomalidomide - POMALYST Celgene CorporationMedical (PDF - 15 KB)Clinical pharmacology (PDF - 1 MB)NoneBPCAPosaconazole - NoxafilMerck Sharp & Dohme Corp.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 252KB)PREAPosaconazole - NoxafilMerckMedical (PDF - 602 KB)Clinical pharmacology (PDF - 645 KB)NonePREAPosaconazole - NoxafilMerck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.Medical (PDF - 8 MB)NoneNonePREAPotassium phosphateFresenius Kabi USA, LLCMedical (PDF - 602 KB)NoneNonePREAPotassium Phosphates - Potassium PhosphateCMP Development LLCMedical (PDF - 3 MB)NoneNonePREAPrasugrel - EffientEli Lilly and CompanyMedical (PDF - 2 MB)Clinical pharmacology (PDF - 911 KB)Statistical (PDF - 290 KB)BPCAPregabalin - LyricaPfizerMedical (PDF - 4 MB)Clinical pharmacology (PDF - 6 KB)Statistical (PDF - 825 KB)PREAPregabalin - Lyrica PF PRISM CVMedical and Statistical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)Medical and Statistical (PDF - 1 MB)PREA Pregabalin - LyricPfizer CTDL Review (PDF - 1 MB) Medical (PDF - 1 MB) Clinical pharmacology(PDF - 1 MB)Statistical (PDF - 2 MB)BOTHPrucalopride - MotegrityTakeda Pharmaceuticals U.S.A Inc.Medical (PDF - 1 MB)NoneNonePREAQuetiapine fumarate - Seroquel and Seroquel XRAstraZeneca Pharmaceuticals LP CTDL Review (PDF - 1 MB) Medical (PDF - 3 MB) Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 739 KB) Statistical (PDF - 785 KB)PREARabeprazole sodium - AcipHex SprinkleEisa Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF 185 KB)BOTHRamucirumab - CyramzaEli Lilly and CompanyMedical (PDF - 198 KB)Clinical pharmacology (PDF - 168 KB)NoneBPCARaltegravir - IsentressMerck Sharp Dohme CorpMedical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)NonePREARaltegravir - IsentressMerck Sharp Dohme CorpCDTL Review (PDF - 5 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF 874 KB)PREARaltegravir - Isentress Merck Sharp Dohme CorpMedical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NoneBOTHRavulizumab-cwvz - Ultomiris Alexion Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNonePREARemdesivir - VekluryGilead Sciences, Inc. Medical (PDF - 1 MB) Medical (PDF - 776 KB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 225 KB) Statistical (PDF - 782 KB) PREARemdesivir - Veklury Gilead Sciences, Inc.CDTL (PDF - 3 MB)NoneNonePREARemdesivir - Veklury Gilead Sciences, Inc.CDTL (PDF - 3 MB)NoneNonePREARemdesivir - VekluryGilead Sciences, Inc.CDTL (PDF - 4 MB)NoneNoneBOTHReslizumab - CinqairTeva Respiratory, LLCMedical (PDF - 5 MB)Clinical pharmacology (PDF - 9 MB)Statistical (PDF - 2 MB)PREARevumenib - RevuforjSyndax Pharmaceuticals, Inc.Medical (PDF - 8 MB)NoneNonePREARifapentin - PriftinSanofi US Services Inc.Medical (PDF - MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 3 MB)PREARilpivirine - Edurant Janssen Products L.P.Medical (PDF - 2 MB)Clinical pharmacology (PDF -138 KB)NonePREARilpivirine - EdurantJanssen Products L.P.Medical (PDF - 41 MB) Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 235 KB) PREARilpivirine - EdurantJanssen Products, LPMedical (PDF - 9 MB)NoneNoneBOTHRivaroxaban - XareltoJanssen Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 10 MB)Statistical (PDF - 797 KB)BOTHRisperidone - Risperdal ConstaJanssen Pharmaceuticals, Inc.DD Summary Review (PDF - 20 KB) CTDL Review (PDF - 1 MB) Medical (PDF - 670KB) Medical (PDF - 667 KB)NoneStatistical (PDF - 237 KB)PREARitlecitinib - LitfuloPfizer, Inc.Medical (PDF - 15 MB)NoneNonePREARituximab-arrx - RiabniAmgen, Inc.Medical (PDF - 7 MB)NoneNonePREARizatriptan - RizaFilmIntelGenx Corp. Medical (PDF - 352 KB) Memo (PDF - 851 KB) Clinical pharmacology (PDF - 220 KB)NonePREARoflumilast - ZoryveArcutis Biotherapeutics, Inc.Medical (PDF - 6 MB)NoneNonePREARoflumilast - ZoryveArcutis Biotherapeutics, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 3 MB)NonePREARoflumilast - ZoryveArcutis Biotherapeutics, Inc.Medical (PDF - 5 MB)NoneNonePREARoflumilast - ZoryveArcutis Biotherapeutics, Inc.Medical (PDF - 6 MB)NoneNonePREARoflumilast - ZoryveArcutis Biotherapeutics, Inc.Medical (PDF - 6 MB)NoneNonePREARoflumilast - ZoryveArcutis Biotherapeutics, Inc.Medical (PDF - 3 MB)NoneNonePREARosuvastatin - Ezallor SprinkleSun Pharmaceutical Industries LimitedMedical (PDF - 27 KB)None NonePREARosuvastatin and ezetimibe - RoszetAlthera Pharmaceuticals, LLC.Medical (PDF - 187 KB)NoneNonePREARufinamide - BanzelEisai Inc.Medical (PDF - 10 MB)Clinical pharmacology (PDF - 3 MB)NoneBPCARuxolitinib - JakafiIncyte Corporation Medical (PDF - 685 KB)Clinical pharmacology (PDF - 533 KB)NoneBPCARuxolitinib - JakafiIncyte CorporationMedical (PDF - 685 KB)NoneNoneBPCARuxolitinib - OpzeluraIncyte CorporationMedical (PDF - 9 MB)NoneNonePREARuxolitinib - OpzeluraIncyte CorporationMedical (PDF - 7 MB)NoneNonePREARuxolitinib - OpzeluraIncyte CorporationMedical (PDF - 4 MB)NoneNonePREASacubitril-valsartan - EntrestoNovartis Pharmaceuticals Corp.Medical (PDF - 685 KB)Clinical pharmacology (PDF - 533 KB)Statistical (PDF - 1 MB)BPCASacubitril-valsartan - EntrestoNovartis Pharmaceuticals Corp. CDTL (PDF - 727 KB) Medical (PDF - 9 MB) Clinical pharmacology (PDF - 6 MB)NonePREASapropterin dihydrochloride - KuvanBioMarin Pharmaceutical Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)NoneBPCASaquinavir mesylate - InviraseHoffmann La-Roche, Inc.orporated c/o Genentech, Inc.Medical (PDF -1 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)BOTHSarecycline - SeysaraAllergan, Inc. Medical (PDF -1 MB) NoneNonePREASarilumab- KevzaraSanofi US Services Inc.Medical (PDF - 4 MB)NoneNonePREASaxagliptin and metformin hydrochloride - Kombiglyze XRAstraZeneca ABMedical (PDF - 2 MB) Clinical pharmacology (PDF - 8 MB) Clinical pharmacology memo (PDF - 8 MB) Statistical (PDF - 1 MB)PREASaxagliptin - OnglyzaAstraZeneca ABMedical (PDF - 2 MB) Clinical pharmacology (PDF - 8 MB) Clinical pharmacology memo (PDF - 8 MB) Statistical (PDF - 1 MB)PREASecnidazole - SolosecLupin Pharmaceuticals, Inc.Medical (PDF 4 MB) NoneNonePREASecnidazole - SolosecLupin Pharmaceuticals, Inc. (A subsidiary of Lupin Inc.)Medical (PDF 2 MB)NoneNonePREASecukinuma - Cosentyx Novartis Pharmaceuticals CorporationMedical (PDF - 6 MB) NoneNonePREASelegiline - EmsamSomerset PharmaceuticalsMedical (PDF - 1 MB) Medical 2 (PDF - 1 MB) Medical Secondary 1 (PDF - 349 KB) Medical Secondary 2 (PDF - 188 KB)NoneNonePREASelenious Acid - Selenious AcidAmerican Regent, Inc.Medical (PDF - 8 MB)NoneNonePREASelenious Acid - Selenious AcidAmerican Regent, Inc.Medical (PDF - 8 MB)NoneNonePREASegesterone acetate and ethinyl estradiol vaginal systems - Annovera The Population Council, Inc.Medical (PDF - 5 MB)NoneNonePREASemaglutide - WegovyNovo Nordisk Inc.Medical (PDF - 8 MB)Clinical pharmacology (PDF - 16 MB)Statistical (PDF - 869 KB)PREASemaglutide - WegovyNovo Nordisk Inc.CDTL (PDF - 721 KB)Clinical pharmacology (PDF - 1 MB)NonePREASerdexmethylphenidate and dexmethylphenidate - AzstarysCommave TherapeuticsMultidisciplinary (PDF - 7 MB)NoneNonePREASevelamer Carbonate - RenvelaGenzyme/SanofiMedical (PDF - 745 KB)Clinical pharmacology (PDF - 542 KB)Statistical (PDF - 541KB)PREA Sitagliptin - Januvia, Janumet & Janumet XR Merck Sharp & Dohme Corp.: CDTL (PDF - 1 MB) Medical (PDF - 4 MB) Clinical pharmacology (PDF - 339 KB)Statistical (PDF - 623 KB)BOTHSildenafil - RevatioPfizer, Inc.Medical (PDF - 6 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 508 KB)BOTHSodium oxybate - XyremJazz Pharmaceuticals Medical (PDF - 193 KB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 508 KB)BPCASodium phenylbutyrate - OlpruvaAcer Therapeutics Inc.Medical (PDF - 24 KB)NoneNonePREASodium picosulfate, magnesium oxide, and anhydrous citric acid - PrepopikFerring Pharmaceuticals Inc.Medical (PDF - 193 KB)NoneNonePREA Sodium sulfate, potassium sulfate, and magnesium sulfate - Suprep Bowel Prep Kit Braintree Laboratories, Inc. Medical (PDF - 193 KB) NoneNonePREASodium picosulfate, magnesium oxide and anhydrous citric acid - ClenpiqFerring Pharmaceuticals Inc.CDTL (PDF - 1 MB)NoneNonePREASofpironium - SofdraBotanix SB Inc. Uniview (PDF - 4 MB) Medical (PDF - 133 KB) NoneNonePREASpinosad - NatrobaParaPRO, LLCMedical (PDF - 854 KB)Clinical pharmacology (PDF - 171 KB)NonePREASofosbuvir - SovaldiGilead Sciences, Inc.Medical and CDTL (PDF - 345 KB)Clinical pharmacology (PDF - 511 KB)NonePREASofosbuvir - SovaldiGilead Sciences, Inc.Medical (PDF - 218 KB)NoneNonePREASofosbuvir and velpatasvir - EpclusaGilead Sciences, Inc.Medical (PDF - 218 KB)Clinical pharmacology (PDF - 511 KB)NonePREASofosbuvir and velpatasvir - Epclusa Gilead Sciences, Inc.Medical (PDF - 287 KB)Clinical pharmacology (PDF - 4 MB)NoneBOTHSolifenacin succinate - VESIcareAstellas Pharma Global Development, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 933 KB)Statistical PDF - 960 KB)BOTHSolifenacin succinate - VESIcareAstellas Pharma Global Development, Inc.Medical (PDF - 3 MB) CDTL (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 960 KB)BOTHSpinosad - NatrobaParaPRO LLCMedical (PDF - 458 KB)NoneNonePREASucroferric oxyhydroxide - VelphoroVifor Fresenius Medical Care Renal Pharma France Medical (PDF - 1 MB) CDTL (PDF - 1 MB) Multidisciplinary (PDF - 1 MB) NoneNonePREASugammadex - Bridion Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Medical (PDF - 3 MBClinical pharmacology (PDF - 2 MB)Statistical (PDF - 2 MB)PREASugammadex - BridionMerck Sharp & Dohme LLCCDTL (PDF - 2 MB) Clinical pharmacology (PDF - 612 KB) Clinical pharmacology correction (PDF - 612 KB) Statistical (PDF - 509 KB)BOTHSulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - LumasonBracco Diagnostics Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 792 KB)PREASulfur Hexafluoride Lipid-Type A Microspheres - LumasonBracco Diagnostics, Inc.Medical (PDF - 3 MB) CDTL (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 859 KB)PREASulfur Hexafluoride Lipid-Type A Microspheres - Lumason Bracco Diagnostics, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 843 KB)PREASumatriptan/Naproxen - TreximetPernix TherapeuticsMedical (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF -843 KB) Statistical Addendum (PDF - 702 KB)BOTHSunitinib malate - Sutent C.P. Pharmaceuticals International C.V.CDTL (PDF - 680 KB)None NoneBPCATacrolimus - Astagraf XL Astellas Pharma US, Inc. Medical (PDF - 749 KB)NoneNonePREATadalafil - CialisEli Lilly and CompanyMedical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)NoneBPCATapentadol - NucyntaCollegium Pharmaceutical, Inc.CDTL - DD (PDF - 9 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF -700 KB)PREATapentadol - NucyntaCollegium Pharmaceutical, Inc.Medical (PDF - 1 MB)NoneNoneBPCATavaborole - Kerydin Anacor Pharmaceuticals, Inc.Multi-disciplinary review (PDF - 3 MB)NoneNoneBOTHTazarotene - ArazloBausch Health US, LLCClinical (PDF - 1 MB)NoneNonePREATbo-filgrastim - Granix Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D CDTL (PDF - 176 KB) Clinical (PDF - 196 KB) Clinical pharmacology (PDF - 434 KB)NoneBOTHTechnetium 99m Tilmanocept - LymphoseekCardinal Health 414, LLCMultidisciplinary (PDF - 2 MB)NoneNonePREAKit for the Preparation of Technetium Tc 99m Succimer Injection -NephroScanTheragnostics IncMedical (PDF - 5 MB)NoneNonePREATedizolid phosphate - Sivextro Cubist Pharmaceuticals, LLCMedical (PDF - 9 MB)NoneNonePREATedizolid phosphate - SivextroCubist Pharmaceuticals LLCMedical (PDF - 9 MB)NoneNonePREATeduglutide - GattexShire-NPS Pharmaceuticals, Inc.Medical (PDF - 9 MB)NoneNonePREATenofovir alafenamide - VemlidyGilead Sciences, IncMedical (PDF - 2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 624 KB)PREATenofovir alafenamide - VemlidyGilead Sciences, IncMedical (PDF - 3 MB)NoneNonePREATenofovir disoproxil fumarate - VireadGilead SciencesMedical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 1 MB)PREATenofovir disoproxil fumarate - VireadGilead SciencesCDTL (PDF - 873 KB)Clinical pharmacology (PDF - 180 KB)Statistical (PDF - 149 KB) BOTHTeplizumab-mzwv -TzieldProvention Bio, Inc. CDTL (PDF - 5 MB) Medical (PDF - 284 KB) Clinical pharmacology (PDF - 6 MB)NonePREATeriflunomide - Aubagio Sanofi CTDL (PDF - 3 MB) Clinical (PDF - 3 MB) Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 410 KB)BOTHTetracaine hydrochloride - Steri-UnitAlcon Research, Ltd.DD Medical Summary (PDF - 2 MB) Medical (PDF - 1 MB)Clinical pharmacology (PDF - 158 KB)Statistical (PDF - 2 MB)PREATetracaine HCl and Oxymetazoline HCl - Kovanaze St. Renatus, LLCMedical (PDF - 12 MB)Clinical pharmacology (PDF - 11 MB)Statistical (PDF - 2 MB)PREATezepelumab -Tezspir AstraZenecaMedical (PDF - 10 MB)NoneNonePREATicagrelor - Brilinta AstraZeneca Pharmaceuticals LPMedical (PDF - 10 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 325 KB)BPCATilmanocept - Lymphoseek Cardinal Health 414, LLCMedical (PDF - 2 MB)NoneNonePREATiotropium bromide - Spiriva RespimatBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 12 MB) Medical Addendum (PDF - 418 KBClinical pharmacology (PDF - 6 MB)Statistical (PDF - 1 MB) Statistical Addendum (PDF - 327 KB)PREATiotropium bromide - Spiriva Respimat Boehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 5 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 432 KB)BOTHTobramycin 300 mg/4mL inhalation solution - BethkisCornerstone TherapeuticsMedical (PDF - 5 MB)Clinical pharmacology (PDF - 78 KB)Statistical (PDF - 687 KB)PREATocilizumab - Actemra Genentech, Inc. Medical (PDF - 72 KB) Medical (PDF - 109 KB) Clinical pharmacology (PDF - 195 KB)NonePREATocilizumab - ActemraGenentech, Inc.Medical (PDF - 8 MB)NoneNoneBOTHTocilizumab - ActemraGenentech, Inc.Medical (PDF - 7 MB)NoneNonePREATocilizumab-bavi - TofidenceBiogen MA IncMedical (PDF - 5 MB)NoneNonePREATocilizumab-aazg -TyenneFresenius Kabi USA, LLC CDTL (PDF - 42K B) Medical (PDF - 8 MB) NoneNonePREATofacitinib - XeljanzPfizer, Inc.Medical (PDF - 8 MB)NoneNonePREATofacitinib - XeljanzPF PRISM CVMedical (PDF - 1 MB)Clinical pharmacology (PDF - 168 KB)NoneBPCATofacitinib - Xeljanz Pfizer, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 168 KB)NoneBPCATopiramate - TopamaxJanssen Pharmaceuticals, Inc.Medical (PDF - 8 MB)NoneStatistical (PDF - 881 KB)PREATopiramate - Eprontia Azurity Pharmaceuticals, Inc.Medical (PDF - 669 KB)Clinical pharmacology (PDF - 565 KB)NonePREATrabectedin - YondelisJanssen Products, LPMedical (PDF - 3 MB)Clinical pharmacology (PDF - 683 KB)NoneBPCATrace elements injection 4 - TralementAmerican Regent, Inc.Medical (PDF - 3 MB)NoneNonePREATrace elements injection 4 - TralementAmerican Regent, Inc.Medical (PDF - 321 KB)NoneNonePREATralokinumab-ldrm - AdbryLEO Pharma A/S c/o LEO Pharma Inc Unireview (PDF - 4 MB) Medical (PDF - 32 KB) NoneNonePREATrametinib - MekinistNovartis Pharmaceuticals Corporation Medical (PDF - 18 MB)NoneNonePREATrametinib - MekinistNovartis Pharmaceuticals CorporationMedical (PDF - 800 KB)Clinical pharmacology (PDF - 616 KB)NoneBPCATranexamic acid - LystedaFerring Pharmaceuticals, Inc.NoneClinical pharmacology (PDF - 1 MB)NonePREATremelimumab-actl - ImjudoAstraZeneca ABMedical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)NonePREATretinoin lotion - Altreno Dow Pharmaceutical Sciences, Inc.Medical (PDF - 3 MB)NoneNonePREATretinoin and benzoyl peroxide - Twyneo Sol-Gel Technologies Ltd. c/o B&H Consulting Services Inc.Medical (PDF - 2 MB)NoneNonePREATrifarotene - AkliefGalderma Research and DevelopmentMedical (PDF - 3 MB)NoneNonePREATrofinetide - Daybue Acadia Pharmaceuticals Inc Medical (PDF - 212 KB) Medical (PDF - 6 MB) Clinical pharmacology (PDF - 6 MB) Statistical (PDF - 2 MB) Statistical Errata (PDF - 28 KB) BPCATropicamide and phenylephrine - MYDCOMBIEyenovia, Inc.CDTL - DD (PDF - 6 MB)NoneStatistical (PDF - 2 MB)PREAUpadacitinib - Rinvoq AbbVie Inc.Medical (PDF - 10 MB)NoneNonePREAUpadacitinib - Rinvoq and Rinvoq LQAbbVie Inc.Medical (PDF - 4 MB)NoneNonePREAUstekinumab-aauz - OtulfiFresenius Kabi USA, LLCMedical (PDF - 558 KB)NoneNonePREAUstekinumab-aekn - SelarsdiAlvotech USA Inc CDTL (PDF - 178 KB) Medical (PDF - 507 KB) NoneNonePREAUstekinumab-srlf - ImuldosaAccord BioPharma, Inc.Medical (PDF - 6 MB)NoneNonePREAUstekinumab - StelaraJanssen Biotech, Inc.Medical (PDF - 352 MB)Clinical pharmacology (PDF - 3 MB)NonePREAUstekinumab - StelaraJanssen Biotech, Inc.Medical (PDF - 8 MB)NoneNonePREAUstekinumab - StelaraJanssen Biotech Inc. CDTL (PDF - 593 KB) Medical (PDF - 5 MB) Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 275 KB)PREAUstekinumab-stba - SteqeymaCELLTRION, Inc.Medical (PDF - 29 MB)NoneNonePREAUstekinumab-aekn - SelarsdiAlvotech USA Inc. PharmaLex US Corporation CDTL (PDF - 123 KB) Medical (PDF - 5 MB) Clinical pharmacology (PDF - 9 KB)NonePREAValganciclovir hydrochloride - ValcyteRoche Palo Alto LLC c/o Genentech, IncorporatedMedical (PDF - 3 MB)Clinical pharmacology (PDF - 6 MB)NonePREAValsartan - DiovanNovartis Pharmaceuticals CorporationMedical (PDF - 2 MB)NoneNonePREA Varenicline - Chantix PF Prism C V NoneClinical pharmacology (PDF - 3 MB)NoneBOTHVigabatrin - SabrilLundbeck LLC.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 698 KB)BOTHVilazodone hydrochloride - Viibryd Allergan Sales, LLCMedical (PDF - 3 MB)NoneNoneBOTHViloxazine extended release capsules - Qelbree Supernus Pharmaceuticals, Inc. Medical (PDF - 13 KB) Medical (PDF - 13 MB) NoneNonePREAViloxazine extended-release capsules - QelbreeSupernus Pharmaceuticals, Inc.Medical (PDF - 2 MB)NoneNonePREAVortioxetine - Trintellix Takeda Pharmaceuticals, USA, Inc.Medical (PDF - 3 MB)NoneNoneBOTHVortioxetine - TrintellixTakeda Pharmaceuticals, USA, Inc.Medical (PDF - 3 MB)NoneNoneBOTHVoriconazole - VendPF PRISM C.V. Medical (PDF - 2 MB) Medical PDF - 200 KB) Clinical Pharmacology (PDF - 1 MB)Statistical (PDF - 200 KB)PREAXenon Xe 129 hyperpolarized - XenoviewPolarean Inc.Medical PDF - 200 KB)NoneNonePREAXenon Xe 129 hyperpolarized - XenoviewPolarean Inc.CDTL (PDF - 200 KB)Clinical Pharmacology (PDF - 1 MB)NonePREAZinc sulfate - None American Regent, Inc.Medical (PDF - 4 MB)NoneNonePREAZiprasidone - Geodon Viatris Specialty LLCMedical (PDF - 2 MB)NoneNonePREAZoliflodacin - Nuzolvence NEWEntasis Therapeutics, Inc.Medical (PDF - 9 MB)NoneNonePREAZolmitriptan - ZomigAstraZeneca Pharmaceuticals LPMedical (PDF - 5 MB)NoneStatistical (PDF - 3 MB)PREA Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)