List of Determinations

List of Determinations Including Written Request Pediatric Exclusivity Determinations Made under Section 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007. In addition, it provides a link to a copy of the Written Request and any amendments. NOTE: Only applications held by the identified sponsor were granted pediatric exclusivity. We will update this page each time a determination is made. The administrative amendments issued during the summer of 2002 and spring of 2004, which cover the passage of the Best Pharmaceuticals for Children Act on January 4, 2002, and the requirement for submitted reports to include more specific information on racial and ethnic minorities, respectively, may not be listed below for original Written Requests that predate their release (e.g., bicalutamide). Find the Pediatric Exclusivity Determinations in the FDA Archive N=191 | Drug | Sponsor | Determination Date | Written Request and Related Documents | |---|---|---|---| | Abacavir/ dolutegravir/ lamivudine | ViiV Healthcare Company | 6/7/2023 | - Written Request [PDF - 465 KB] - Amendment 1 [PDF - 201KB] - Amendment 2 [PDF - 523 KB] | | Abatacept | BMS | 2/14/2017 | - Written Request [PDF - 54KB] - Amendment 1 [PDF - 78KB] | | Acetaminophen | Mallinckrodt | 7/11/2016 | - Written Request [PDF -157KB] - Amendment 1 [PDF -168KB] - Amendment 2 [PDF -160KB] - Amendment 3 [PDF -240KB] | | Afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | 3/8/2022 | - Written Request [PDF -150 KB] - Amendment 1 [PDF - 118 KB] - Amendment 2 [PDF - 153 KB] - Amendment 3 [PDF - 376 KB] - Amendment 4 [PDF - 326 KB] | | Aflibercept | Regeneron Pharmaceuticals | 10/18/2022 | - Written Request [PDF -150 KB] | | Albuterol | GlaxoSmithKline | 8/27/2008 | - Written Request [PDF -337KB] - Amendment 1 [PDF -547KB] - Amendment 2 [PDF -172KB] - Amendment 3 [PDF -204KB] - Amendment 4 [PDF -467KB] | | Alfuzosin | Sanofi Aventis | 9/7/2010 | - Written Request [PDF -207KB] - Amendment 1 [PDF -58KB] - Amendment 2 [PDF -267KB] | | Aliskiren | Noden Pharma DAC | 10/3/2017 | - Written Request [PDF - 54 KB] - Amendment 1 [PDF - 47 KB] - Amendment 2 [PDF - 24 KB] - Amendment 3 [PDF - 215 KB] | | Almotriptan | Johnson & Johnson Pharmaceutical Research & Development | 1/13/2009 | - Written Request [PDF -197KB] - Reissue [PDF -102KB] | | Amphetamine | Shire | 8/18/2019 | - Written Request [PDF -157 KB] - Amendment 1 [PDF -168 KB] - Amendment 2 [PDF -160 KB] | | Anastrozole | AstraZeneca | 11/14/2007 | - Written Request - Amendment 4 [PDF - 416KB] | | Apixiban | Bristol-Myers Squibb | 4/14/2025 | - Written Request [PDF - 882KB] - Amendment 1 [PDF - 308KB] - Amendment 2 [PDF - 222KB] - Amendment 3 [PDF - 361KB] | | Apremilast | Amgen Inc. | 4/22/2024 | - Written Request [PDF - 146 KB] - Amendment 1 [PDF - 168 KB] - Amendment 2 [PDF - 232KB] | | Aripiprazole | Otsuka | 11/14/2007 | - Written Request [PDF -499KB] | | Asenapine | Forest Labs | 3/3/2015 | - Written Request [PDF - 704KB] - Amendment 1 [PDF - 214KB] - Amendment 2 [PDF - 209KB] - Amendment 3 [PDF - 98KB] - Amendment 4 [PDF - 230KB] | | Atazanavir | BMS | 6/23/2015 | - Written Request [PDF -100KB] - Amendment 1 [PDF -280KB] - Reissue Amendment 1 [PDF -89KB] - Reissue Amendment 2 [PDF -122KB] - Reissue Amendment 3 [PDF -121KB] - Reissue Amendment 4 [PDF -134KB] - Reissue Amendment 5 [PDF -114KB] - Reissue Amendment 6 [PDF -114KB] | | Atezolizumab | Genentech | 9/22/2020 | - Written Request [PDF - 263 KB] - Amendment 1 [PDF - 329 KB] | | Axitinib | Pfizer, Inc. | 7/2/2024 | - Written Request [PDF - 830 KB] - Amendment 1 [PDF - 1.06 MB] - Amendment 2 [PDF - 1,014 KB] - Amendment 3 [PDF - 282 KB] | | Azelastine/Fluticasone and Azelastine | Meda Pharmaceuticals | 3/23/2015 | - Written Request [PDF -122 KB] | | Bendamustine | Cephalon | 5/24/2012 | - Written Request [PDF -116 KB] - Amendment 1 [PDF -159 KB] - Amendment 2 [PDF -113 KB] | | Berotralstat | BioCryst Pharmaceuticals, Inc. | 8/29/2025 | - Written Request [PDF - 396 KB] - Amendment 1 [PDF - 836 KB] | | Bezlotoxumab | Merck Sharpe and Dohme | 5/12/2023 | - Written Request [PDF - 315 KB] - Amendment 1 [PDF - 944 KB] | | Bicalutamide | AstraZeneca | 9/19/2008 | - Written Request [PDF -256 KB] - Amendment 1 [PDF -264 KB] - Amendment 3 [PDF -236 KB] - Amendment 4 [PDF -185 KB] - Amendment 5 [PDF -297 KB] - Amendment 6 [PDF -182 KB] | | Bivalirudin | The Medicines Company | 6/17/2009 | - Written Request [PDF -504 KB] | | Blinatumomab | Amgen | 6/13/2023 | - Written Request [PDF - 256 KB] - Amendment 1 [PDF - 264 KB] - Amendment 2 [PDF - 236 KB] - Amendment 3 [PDF - 185 KB] | | Bosutinib | PF Prism, C.V. | 9/7/ 2023 | - Written Request [PDF - 256 KB] - Amendment 1 [PDF - 264 KB] - Amendment 2 [PDF - 236 KB] - Amendment 3 [PDF - 185 KB] - Amendment 4 [PDF - 185 KB] | | Bortezomib | Millennium Pharmaceuticals | 8/14/2015 | - Written Request [PDF -116KB] - Amendment 1 [PDF -159KB] - Amendment 2 [PDF -113KB] | | Brentuximab vedotin | Seagen, Inc. | 11/18/2022 | - Written Request [PDF -116 KB] - Amendment 1 [PDF -159 KB] | | Brexpiprazole | Otsuka Pharmaceutical Development & Commercialization | 5/2/2024 | - Written Request [PDF -821 KB] - Amendment 1 [PDF - 82 KB] - Amendment 2 [PDF -152 KB] - Amendment 3 [PDF -156 KB] - Amendment 4 [PDF -303 KB] | | Budesonide/Formoterol | AstraZeneca | 1/25/2017 | - Written Request [PDF - 181KB] - Amendment 1 [PDF - 178KB] - Amendment 2 [PDF - 195KB] - Amendment 3 [PDF - 172KB] - Amendment 4 [PDF - 276KB] | | Cabazitaxel | Sanofi Aventis | 5/18/2017 | - Written Request [PDF - 91 KB] - Amendment 1 [PDF - 2345 KB] - Amendment 2 [PDF - 250 KB] | | Calcipotriene/Betamethasone | Leo Pharma | 7/15/2019 | - Written Request [PDF - 109 KB] | | Canagliflozin | Janssen Pharmaceuticals, Inc. | 12/9/2024 | - Written Request [PDF - 157 KB] - Amendment 1 [PDF - 149 KB] - Amendment 2 [PDF - 169 KB] - Amendment 3 [PDF - 205 KB] - Amendment 4 [PDF - 194 KB] - Amendment 5 [PDF - 135 KB] - Amendment 6 [PDF - 138 KB] | | Candesartan | AstraZeneca Pharmaceuticals LP | 7/20/2009 | - Written Request [PDF - 240 KB] - Amendment 1 [PDF - 215 KB] - Amendment 2 [PDF - 254 KB] - Amendment 3 [PDF - 155 KB] - Amendment 4 [PDF - 145 KB] - Amendment 5 [PDF - 176 KB] | | Capecitabine | Hoffman-La Roche, Inc. | 8/28/2013 | - Written Request [PDF - 319 KB] - Amendment 1 [PDF - 96 KB] - Amendment 2 [PDF - 136 KB] - Amendment 3 [PDF - 156 KB] | | Carfilzomib | Onyx pharmaceuticals | 5/19/2025 | - Written Request [PDF - 789 KB] - Amendment 2 [PDF - 306 KB] - Amendment 3 [PDF - 262 KB] - Amendment 4 [PDF - 323 KB] | | Cariprazine hydrochloride | Abbvie Inc. | 12/11/2025 | - Written Request [PDF - 173 KB] - Amendment 1 [PDF - 92 KB] - Amendment 2 [PDF - 125 KB] - Amendment 3 [PDF - 246 KB] - Amendment 4 [PDF - 298 KB] | | Caspofungin | Merck & Co., Inc. | 4/15/2008 | - Written Request - Amendment 4 [PDF - 91 KB] | | Cemiplimab | Regeneron Pharmaceuticals, Inc. | 10/24/2025 | - Written Request [PDF - 66 KB] - Written Request Reissue [PDF - 323 KB] | | Cetirizine | Nicox Ophthalmics | 8/29/2016 | - Written Request [PDF -136 KB] - Written Request - Amendment 1 [PDF -171 KB] | | Clopidogrel | Sanofi Aventis | 1/20/2011 | - Written Request [PDF -172 KB] - Amendment 1 [PDF -116 KB] | | Cobimetinib | Genentech, Inc. | 7/19/2022 | - Written Request [PDF -139 KB] - Written Request 2 [PDF - 61 KB] - Amendment 1 [PDF -159 KB] | | Colesevelam | Daiichi Sankyo Pharma | 2/17/2009 | - Written Request [PDF -208KB] - Amendment 1 [PDF -112KB] - Amendment 2 [PDF -69KB] - Amendment 3 [PDF -115KB] | | Crisaborole | Pfizer | 2/21/2020 | - Written Request [PDF - 45 KB] - Amendment 1 [PDF - 71 KB] | | Cysteamine | Horizon | 12/12/2017 | - Written Request [PDF - 45 KB] - Amendment 1 [PDF - 71 KB] | | Dabigatran | Boehringer Ingelheim Pharmaceuticals, Inc. | 2/12/2021 | - Written Request [PDF - 41 KB] - Amendment 1 [PDF - 160 KB] | | Dabrafenib | Novartis | 2/9/2023 | - Written Request [PDF - 275 KB] - Amendment 1 [PDF - 208 KB] - Amendment 2 [PDF - 414 KB] - Amendment 3 [PDF - 286 KB] - Amendment 4 [PDF - 654 KB] - Amendment 5 [PDF - 677 KB] | | Dapagliflozin | AstraZeneca AB | 5/30/2024 | - Written Request [PDF - 742 KB] - Written Request Reissue [PDF - 69 KB] - Amendment 1 [PDF - 141 KB] - Amendment 2 [PDF - 104 KB] - Amendment 3 [PDF - 95 KB] | | Darunavir | Tibotec | 6/7/2011 | - Written Request [PDF - 101KB] - Amendment 1 [PDF - 102KB] | | Daunorubicin and Cytarabine | Jazz Pharmaceuticals | 1/9/2026 | - Written Request [PDF - 142KB] - Amendment 1 [PDF - 329KB] - Amendment 2 [PDF - 347KB] | | Deutetrabenazine | Teva Branded Pharmaceutical Products | 5/5/2021 | - Written Request [PDF - 158 KB] | | Dexmedetomidine | Hospira | 3/12/2013 | - Written Request [PDF - 146KB] - Amendment 1 [PDF - 150KB] - Amendment 2 [PDF - 266KB] | | Difluprednate | Alcon | 3/21/2013 | - Written Request [PDF - 79KB] - Amendment 1 [PDF - 42KB] | | Docetaxel | Sanofi Aventis | 3/17/2010 | - Written Request [PDF -126KB] | | Dulaglutide | Eli Lilly and Company | October 4, 2022 | - Written Request [PDF -151 KB] - Amendment 1 [PDF - 158 KB] - Amendment 2 [PDF - 82 KB] - Amendment 3 [PDF - 132 KB] | | Duloxetine | Eli Lilly | 7/2/2012 | - Written Request [PDF -76KB] - Amendment 1 [PDF -151KB] - Amendment 2 [PDF -145KB] | | Efavirenz | BMS | 1/29/2013 | - Written Request [PDF -122KB] - Amendment 1 [PDF -79KB] - Amendment 2 [PDF -136KB] - Amendment 3 [PDF -130KB] - Amendment 4 [PDF -151KB] - Amendment 5 [PDF -92KB] - Amendment 6 [PDF -67KB] - Amendment 7 [PDF -116KB] | | Eltrombopag | Novartis | 8/14/2015 | - Written Request [PDF -699KB] - Amendment 1 [PDF -212KB] | | Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide | Gilead Sciences, Incorporated | 9/13/2021 | - Written Request [PDF - 63 KB] - Amendment 1 [PDF - 248 KB] | | Empagliflozin/Empagliflozin and Metformin hydrochloride | Boehringer Ingelheim Pharmaceuticals | 6/9/2023 | - Written Request [PDF - 48 KB] - Amendment 1 [PDF - 48 KB] - Amendment 2 [PDF - 104 KB] | | Entecavir | BMS | 12/5/2013 | - Written Request [PDF -112KB] - Amendment 1 [PDF -133KB] - Amendment 2 [PDF -135KB] - Amendment 3 [PDF -241KB] | | Eplerenone | Pfizer | 10/24/2007 | - Written Request [PDF -425KB] - Amendment 1 [PDF - 403KB] - Amendment 2 [PDF -143KB] - Amendment 3 [PDF - 114KB] - Memo to File [PDF - 12KB] | | Eribulin Mesylate | Eisai, Inc. | 8/9/2022 | - Written Request [PDF - 164 KB] - Amendment 1 [PDF - 184 KB] - Amendment 2 [PDF - 198 KB] - Amendment 3 [PDF - 230 KB] | | Erlotinib | OSI Pharmaceuticals | 3/18/2015 | - Written Request [PDF -154 KB] - Amendment 1 [PDF -157 KB] | | Esomeprazole | AstraZeneca LP | 5/1/2009 | - Written Request [PDF -243 KB] - Amendment 1 [PDF -235 KB] - Amendment 2 [PDF -235 KB] - Amendment 3 [PDF -242 KB] - Amendment 4 [PDF -249 KB] | | Eszopiclone | Sunovion | 6/29/2012 | - Written Request [PDF -217KB] - Amendment 1 [PDF -245KB] | | Etravirine | Janssen | 6/21/2018 | - Written Request [PDF - 40 KB] - Amendment 1 [PDF - 36 KB] - Amendment 2 [PDF - 50 KB] - Amendment 3 [PDF - 50 KB] - Amendment 4 [PDF - 146 KB] | | Everolimus | Novartis | 7/10/2012 | - Written Request [PDF -145KB] | | Exenatide | AstraZeneca | 4/1/2021 | - Written Request [PDF - 103 KB] - Amendment 1 [PDF - 95 KB] - Amendment 2 [PDF - 106 KB] - Amendment 3 [PDF -127 KB] - Amendment 4 [PDF -125 KB] - Amendment 5 [PDF -103 KB] - Amendment 6 [PDF -103 KB] - Amendment 7 [PDF -566 KB] - Amendment 8 [PDF - 530 KB] | | Ezetimibe | Schering Corporation | 2/14/2008 | - Written Request - Amendment 1 [PDF -220KB] | | Famciclovir | Novartis | 9/21/2009 | - Written Request [PDF -166KB] - Amendment 1 [PDF -177KB] - Amendment 2 [PDF -106KB] - Amendment 3 [PDF -107KB] | | Fenfluramine hydrochloride | Zogenix, Inc | 3/23/2022 | - Written Request [PDF - 112 KB] - Amendment 1 [PDF -45 KB] | | Ferric Oxyhydroxide | Vifor Fresenius Medical Care Renal Pharma France | 6/1/2021 | - Written Request [PDF - 206 KB] - Amendment 1 [PDF - 177 KB] - Written Request Reissue [PDF - 186 KB] | | Fesoterodine | Pfizer | 6/3/2021 | - Written Request [PDF - 185 KB] - Amendment 1 [PDF - 349 KB] - Amendment 2 [PDF - 225 KB] - Amendment 3 [PDF - 231 KB] | | Fidaxomicin | Cubist | 12/13/2019 | - Written Request [PDF - 399 KB] | | Finafloxacin | Alcon | 8/25/2014 | - Written Request [PDF -66KB] | Fingolimod | Novartis | 4/16/2018 | - Written Request [PDF - 34 KB] - Amendment 1 [PDF - 71 KB] | | Fluticasone & Fluticasone/Salmeterol | Teva Pharmaceutical Industries Ltd. | 6/10/2021 | - Written Request [PDF -155 KB] - Amendment 1 [PDF - 684 KB] - Amendment 2 [PDF - 632 KB] | | Fluticasone furoate vilanterol trifenatate | GlaxoSmithKline | 4/26/2023 | - Written Request [PDF -137 KB] - Amendment 1 [PDF - 684 KB] - Amendment 2 [PDF - 632 KB] | | Fosamprenavir | ViiV Healthcare | 1/10/2012 | - Written Request [PDF -173KB] - Amendment 1 [PDF -133KB] - Amendment 2 [PDF -167KB] - Amendment 3 [PDF -57KB] - Amendment 4 [PDF -109KB] - Amendment 5 [PDF -115KB] | | Fosaprepitant | Merck | 3/23/2018 | - Written Request [PDF - 80 KB] - Amendment 1 [PDF - 139 KB] - Amendment 2 [PDF - 85 KB] - Amendment 3 [PDF - 57 KB] - Amendment 4 [PDF - 109KB] | | Fulvestrant | AstraZeneca | 2/1/2011 | - Written Request [PDF -62 KB] - Amendment 1 [PDF -63 KB] | | Gatifloxacin | Allergan | 5/19/2009 | - Written Request [PDF -1 50 KB] - Amendment 1 [PDF - 63KB] | | Glecaprevir/Pibrentasvir | AbbVie, Inc. | 5/18/2021 | - Written Request [PDF - 62 KB] - Amendment 1 [PDF - 63 KB] - Amendment 2 [PDF - 63 KB] | | Guanfacine | Shire | 10/17/2014 | - Written Request [PDF -150KB] | Halobetasol | Mayne Pharma LLC | 5/21/2021 | - Written Request [PDF - 180 KB] - Amendment 1 [PDF - 396 KB] | | Ibrutinib | Pharmacyclics | 8/8/2022 | - Written Request [PDF - 152 KB] - Amendment 1 [PDF - 108 KB] - Amendment 2 [PDF - 179 KB] | | Ipilimumab | BMS | 7/20/17 | - Written Request [PDF - 253 KB] - Amendment 1 [PDF - 194 KB] | | Isavuconazonium sulfate | Astellas Pharma US Inc. | 11/29/2023 | - Written Request [PDF - 152 KB] - Amendment 1 [PDF - 328 KB] | | Ivacaftor | Vertex Pharmaceuticals Inc. | 5/20/2025 | - Written Request [PDF - 146 KB] - Amendment 1 [PDF - 452 KB] - Amendment 2 [PDF - 157 KB] | | Ixabepilone | BMS | 4/5/2011 | - Written Request [PDF -69KB] - Amendment 1 [PDF - 91KB] - Amendment 2 [PDF - 135KB] | | Ivabradine | Amgen | 3/30/2019 | - Written Request [PDF - 1 MB] - Amendment 1 [PDF - 109 KB] | | Lanadelumab | Takeda Pharmaceuticals U.S.A., Inc. | 12/20/2022 | - Written Request [PDF - 102 KB] - Amendment 1 [PDF - 145 KB | | Lansoprazole | Tap Pharmaceutical Products, Inc. | 7/15/2008 | - Written Request [PDF - 335KB] - Amendment 1 [PDF -276KB] - Amendment 2 [PDF -144KB] - Amendment 3 [PDF -182KB] - Amendment 4 [PDF -519KB] | | Lenvatinib Mesylate | Eisai Inc. | 4/1/2024 | - Written Request [PDF - 845 KB] - Amendment 1 [PDF - 700 KB] - Amendment 2 [PDF - 378 KB] | | Levetiracetam | UCB, Inc. | 6/3/2008 | - Written Request [PDF - 44 KB] - Amendment 1 [PDF - 24 KB] - Reissue 1 [PDF - 27 KB] - Reissue 2 [PDF - 31 KB] - Amendment 2 [PDF - 25 KB] - Amendment 3 [PDF - 34 KB] | | Levocetirizine | UCB, Inc. | 8/25/2009 | - Written Request [PDF -155 KB] | | Linaclotide | AbbVie, Inc. | 10/15/2025 | - Written Request [PDF - 155 KB] - Amendment 1 [PDF - 231 KB] - Amendment 2 [PDF - 357 KB] - Amendment 3 [PDF - 538 KB] | | Linagliptin/Linagliptin and metformin hydrochloride | Boehringer Ingelheim Pharmaceuticals | 6/9/2023 | - Written Request [PDF - 351 KB] - Written Request Reissued [PDF - 161 KB] - Amendment 1 [PDF - 161 KB] | | Liraglutide | Novo Nordisk | 5/1/2019 | - Written Request [PDF - 335 KB] - Amendment 1 [PDF - 276 KB] - Amendment 2 [PDF - 144 KB] | | Lisdexamfetamine | Takeda Pharmaceuticals USA, Inc. | 7/27/2021 | - Written Request [PDF - 197 KB] | | Loteprednol/Tobramycin | Bausch & Lomb | 12/28/2010 | - Written Request [PDF -43KB] - Amendment 1 [PDF -25KB] | | Lopinavir/Ritonavir | Abbott Laboratories | 3/7/2008 | - Written Request [PDF - 151KB] - Amendment 1 [PDF - 125 KB] - Amendment 2 [PDF -125 KB] - Amendment 3 [PDF - 128 KB] - Amendment 4 [PDF - 165 KB] - Amendment 5 [PDF - 58 KB] - Amendment 6 [PDF - 65 KB] | | Lumacaftor/Ivacaftor | Vertex Pharmaceuticals Inc. | 12/11/2024 | - Written Request [PDF - 86 KB] | | Lurasidone | Sunovion | 12/20/2016 | - Written Request [PDF - 241KB] | | Lutetium Lu 177 dotatate | Advanced Accelerator Applications | 4/19/2024 | - Written Request [PDF - 789 KB] - Reissue 1 [PDF - 121 KB] - Amendment 1 [PDF - 535 KB] - Amendment 2 [PDF - 975 KB] | | Macitentan | Janssen Research & Development, LLC | 2/25/2025 | - Written Request [PDF - 168 KB] - Amendment 1 [PDF - 116 KB] | | Maraviroc | ViiV Healthcare Co | 7/29/2020 | - Written Request [PDF - 94 KB] - Amendment 1 [PDF - 134 KB] - Amendment 2 [PDF - 220 KB] - Amendment 3 [PDF - 219 KB] | | Memantine | Forest Labs | 6/16/2014 | - Written Request [PDF - 200 KB] - Amendment 1 [PDF - 266 KB] | | Methylphenidate | Rhodes Pharmaceuticals | 3/15/2019 | - Written Request [PDF - 35 KB] - Amendment 1 [PDF - 595 KB] | | Micafungin | Astellas | 11/14/2019 | - Written Request [PDF - 94 KB] - Amendment 1 [PDF - 91 KB] - Amendment 2 [PDF - 90 KB] - Amendment 3 [PDF - 89 KB] - Amendment 4 [PDF - 82 KB] - Written Request Reissue [PDF - 130 KB] | | Mirabegron | Astellas Pharma Global Development, Inc. | 3/1/2021 | - Written Request [PDF - 154 KB] | | Mometasone/formoterol | Merck | 6/24/2019 | - Written Request [PDF - 71 KB] | | Nilotinib | Novartis | 3/20/2018 | - Written Request [PDF - 35 KB] - Amendment 1 [PDF - 595 KB] - Amendment 2 [PDF - 456 KB] - Amendment 3 [PDF - 490 KB] | | Nintedanib | Boehringer Ingelheim Pharmaceuticals | 10/6/2023 | - Written Request [PDF - 146 KB] - Amendment 1 [PDF - 161 KB] | | Nitric Oxide | INO Therapeutics | 11/2/2010 | - Written Request [PDF -117 KB] | | Nivolumab | 2/2/2023 | - Written Request [PDF - 176 KB] - Amendment 1 [PDF - 41 KB] - Amendment 2 [PDF - 366 KB] - Amendment 3 [PDF - 424 KB] | | | Olmesartan | Daiichi Sankyo | 10/7/2009 | - Written Request [PDF - 29 KB] - Amendment 1 [PDF -271 KB] - Reissue [PDF -130 KB] | | Olopatadine | Alcon Research, Ltd. | 8/12/2009 | - Written Request [PDF -49KB] | | Olopatadine | Alcon Research, Ltd. | 12/16/2014 | - Written Request [PDF -100KB] | | Paclitaxel | Abraxis | 11/8/2019 | - Written Request [PDF - 247 KB] - Amendment 1 [PDF - 182 KB] - Amendment 2 [PDF - 139 KB] - Amendment 3 [PDF - 228 KB] | | Palbociclib | Pfizer, Inc. | 9/10/2025 | - Written Request [PDF - 169 KB] - Amendment 1 [PDF - 454 KB] - Amendment 2 [PDF - 475 KB] - Amendment 3 [PDF - 412 KB] | | Paliperidone | Ortho-McNeil-Janssen Pharmaceuticals, Inc. | 1/5/2011 | - Written Request [PDF -72 KB] - Amendment 1 [PDF -40 KB] - Amendment 2 [PDF -103 KB] | | Palonosetron | Helsinn | 4/10/2014 | - Written Request [PDF -247 KB] - Amendment 1 [PDF -182 KB] - Amendment 2 [PDF -139 KB] - Amendment 3 [PDF -228 KB] | | Pantoprazole | Wyeth Pharmaceuticals, Inc. | 2/17/2009 | - Written Request [PDF -247KB] - Amendment 1 [PDF -182KB] - Amendment 2 [PDF -139KB] - Amendment 3 [PDF -228KB] - Amendment 4 [PDF -237KB] | | Pemetrexed | Eli Lilly | 12/3/2010 | - Written Request [PDF -223KB] - Amendment 1 [PDF -163KB] - Amendment 2 [PDF -80KB] - Amendment 3 [PDF -110KB] | | Phenylephrine/Ketorolac | Omeros | 12/6/2017 | - Written Request [PDF - 309 KB] | | Pimavanserin NEW | Acadia Pharmaceuticals Inc. | 3/10/2026 | - Written Request [PDF - 47 KB] - Amendment 1 [PDF - 118 KB] - Amendment 2 [PDF = 456 KB] | | Pitavastatin | Kowa Research Institute | 3/30/2019 | - Written Request [PDF - 157 KB] - Amendment 1 [PDF - 147 KB] | | Pomalidomide | Celgene Corporation | 10/16/2020 | - Written Request [PDF - 158 KB] - Amendment 1 [PDF - 174 KB] - Amendment 2 [PDF - 65 KB] | | Prasugrel | Eli Lilly | 5/23/16 | - Written Request [PDF -247KB] - Amendment 1 [PDF -182KB] - Amendment 2 [PDF -139KB] | | Quetiapine | AstraZeneca Pharmaceuticals LP | 1/23/2009 | - Written Request [PDF -263KB] - Amendment 1 [PDF -263KB] | | Rabeprazole | Eisai | 12/4/2012 | - Written Request [PDF -230KB] - Amendment 1 [PDF -173KB] - Amendment 2 [PDF -39KB] - Amendment 3 [PDF -239KB] - Amendment 4 [PDF -223KB] - Amendment 5 [PDF -234KB] - Amendment 6 [PDF -317KB] | | Raltegravir | Merck | 8/14/2017 | - Written Request [PDF - 38 KB] - Amendment 1 [PDF - 22 KB] - Amendment 2 [PDF - 53 KB] - Amendment 3 [PDF - 139KB] - Amendment 4 [PDF - 151 KB] | | Ramucirumab | Eli Lilly and Company | 5/14/2025 | - Written Request [PDF - 148 KB] - Amendment 1 [PDF - 147 KB] - Amendment 2 [PDF - 313 KB] - Amendment 3 [PDF - 276 KB] | | Remdesivir | Gilead Sciences, Inc. | January 23, 2024 | - Written Request [PDF - 172 KB] - Amendment 1 [PDF - 22 KB] | | Rilpivirine | Janssen Products, LP. | 1/18/2024 | - Written Request [PDF - 122 KB] - Amendment 1 [PDF - 69 KB] - Amendment 2 [PDF - 56 KB] - Amendment 3 [PDF - 56 KB] - Amendment 4 [PDF - 112 KB] - Amendment 5 [PDF - 89 KB] - Reissue [PDF - 103 KB] - Reissue Amendment 1 [PDF - 1,034 KB] - Reissue Amendment 2 [PDF - 406 KB] | | Risedronate | Procter & Gamble Pharmaceuticals, Inc. | 4/24/2009 | - Written Request [PDF -186KB] - Amendment 1 [PDF -173KB] - Amendment 2 [PDF -190KB] | | Rivaroxaban | Janssen Pharmaceuticals, Inc. | 11/23/2021 | - Written Request [PDF -186 KB] - Amendment 1 [PDF -173 KB] | | Rizatriptan | Merck | 9/20/2011 | - Written Request [PDF -77KB] - Amendment 1 [PDF -113KB] | | Rocuronium | Organon, Inc. | 4/3/2008 | - Written Request - Amendment 6 [PDF -68KB] | | Rosuvastatin | AstraZeneca Pharmaceuticals LP | 7/7/2009 | - Written Request [PDF -160KB] | | Rufinamide | Eisai | 1/13/2015 | - Written Request [PDF -168KB] - Amendment [PDF -239KB] | | Ruxolitinib | Incyte Corporation | 12/1/2022 | - Written Request [PDF - 257 KB] - Amendment 1 [PDF - 264 KB] - Amendment 2 [PDF - 613 KB] | | Sacubitril/Valsartan | Novartis | 9/26/2019 | - Written Request [PDF - 168KB] - Amendment [PDF - 239KB] | | Sapropterin | BioMarin | 3/13/2014 | - Written Request [PDF -121KB] - Amendment [PDF -176KB] | | Saquinavir | Hoffman-La Roche, Inc. | 10/26/2010 | - Written Request [PDF -159KB] [*note for vision impaired users] - Amendment 1 [PDF -107KB] - Amendment 2 [PDF -77KB] - Reissue [PDF -654KB] - Reissue Amendment 1 [PDF -128KB] - Reissue Amendment 2 [PDF -103KB] | | Secukinumab NEW | Novartis | 2/23/2026 | - Written Request [PDF - 254KB] - Amendment 1 [PDF - 229KB] - Amendment 2 [PDF - 288KB] - Amendment 3 [PDF - 288KB] | | Selexipag | Actelion Pharmaceuticals Inc. | 1/16/2025 | - Written Request [PDF - 87KB] | | Selpercatinib | Loxo Oncology Inc. | 12/4/2025 | | | Sildenafil | Pfizer | 2/9/2012 | - Written Request [PDF -107KB] - Amendment 1 [PDF -220KB] - Amendment 2 [PDF -233KB] - Amendment 3 [PDF -90KB] - Amendment 4 [PDF -117KB] - Amendment 5 [PDF -120KB] - Amendment 6 [PDF -159KB] | | Sitagliptin | Merck Sharp & Dohme Corp. | 10/30/2020 | - Written Request [PDF - 245 KB] - Amendment 1 [PDF - 145 KB] - Amendment 2 [PDF - 92 KB] | | Sofosbuvir | Gilead Sciences, Inc. | 7/23/2019 | - Written Request [PDF - 157 KB] - Amendment 1 [PDF - 380 KB] - Amendment 2 [PDF - 253 KB] - Amendment 3 [PDF - 253 KB] | | Sofosbuvir/Ledipasvir | Gilead Sciences, Inc. | 7/23/2019 | - Written Request [PDF - 262 KB] - Amendment 1 [PDF - 262 KB] - Amendment 2 [PDF - 399 KB] - Amendment 3 [PDF - 157 KB] | | Sofosbuvir/Velpatasvir | Gilead Sciences, Inc. | 5/13/2021 | - Written Request [PDF - 165 KB] - Amendment 1 [PDF - 95 KB] - Amendment 2 [PDF - 93 KB] | | Solifenacin | Astellas | 7/20/2017 | - Written Request [PDF - 49 KB] - Amendment 1 [PDF - 54 KB] - Amendment 2 [PDF - 117 KB] - Amendment 3 [PDF - 110 KB] | | Sugammadex | Merck, Sharp & Dohme LLC (Merck) | 12/9/2024 | - Written Request [PDF - 102 KB] - Amendment 1 [PDF - 693 KB] - Amendment 2 [PDF - 826 KB] - Amendment 3 [PDF - 494 KB] - Amendment 4 [PDF - 548 KB] - Amendment 5 [PDF - 426 KB] | | Sumatriptan/Naproxen | GlaxoSmithKline/Pernix | 4/16/2015 | - Written Request [PDF -133KB] | | Tadalafil | Eli Lilly | 11/16/2017 | - Written Request (PDF - 164KB) - Amendment 1 (PDF - 59KB) - Amendment 2 (PDF - 171KB) - Amendment 3 (PDF - 223KB) | | Tamsulosin | Boehringer Ingelheim | 9/17/2009 | - Amendment 1 [PDF -50KB] - Amendment 2 [PDF -68KB] - Amendment 3 [PDF -80KB] | | Tapentadol | Collegium Pharmaceutical Inc. | June 11, 2024 | - Written Request [PDF - 1.4 MB] - Amendment 1 [PDF - 184 KB] - Amendment 2 [PDF - 833 KB] - Amendment 3 [PDF - 763 KB] - Amendment 4 [PDF - 89 KB] - Amendment 5 [PDF - 311 KB] | | Tavaborole | Anacor | 7/18/2018 | - Written Request (PDF - 106 KB) - Amendment 1 (PDF - 115 KB) | | Tbo-filgrastim | Sicor | 7/18/2018 | - Written Request (PDF - 204 KB) - Amendment 1 (PDF - 242 KB) | | Technetium Tc99 sestamibi | BMS | 1/11/2008 | - Written Request- Amendment 2 [PDF -62KB] | | Teduglutide | Shire - NPS Pharmaceuticals | 3/7/2019 | - Written Request [PDF - 243 KB] - Amendment 1 [PDF - 251 KB] - Amendment 2 [PDF - 184 KB] | | Temsirolimus | Pfizer | 2/28/2012 | - Written Request [PDF -204KB] [*note for vision impaired users] - Amendment 1 [PDF -135KB] - Amendment 2 [PDF -192KB] - Amendment 3 [PDF -35KB] - Amendment 4 [PDF -84KB] - Amendment 5 [PDF -80KB] | | Tenofovir | Gilead Sciences, Inc. | 9/6/2011 | - Written Request [PDF -57KB] - Amendment 1 [PDF -32KB] - Amendment 2 [PDF -50KB] - Amendment 3 [PDF -73KB] - Amendment 4 [PDF -111KB] - Amendment 5 [PDF -72KB] | | Tenofovir | Gilead Sciences, Inc. | 11/15/2018 | - Written Request [PDF - 173 KB] - Amendment 1 [PDF - 263 KB] - Amendment 2 [PDF - 43 KB] | | Teriflunomide | Sanofi Aventis | 3/31/2021 | - Written Request [PDF - 76 KB] - Written Request Reissued [PDF - 84 KB] | | Ticagrelor | AstraZeneca | 4/8/2022 | - Written Request [PDF - 182 KB] - Amendment 1 [PDF - 789 KB] | | Tiotropium | Boehringer Ingelheim Pharmaceuticals, Inc. | 12/14/16 | - Written Request [PDF - 128KB] | | Tipranavir | Boehringer Ingelheim Pharmaceuticals, Inc. | 3/7/2008 | - Written Request [PDF -95KB] | | Tocilizumab | Genentech/Hoffmann-La Roche | 7/18/2018 | - Written Request [PDF -240 KB] - Amendment 1 [PDF -292 KB] | | Tofacitinib | Pfizer, Inc | 02/19/2025 | - Written Request [PDF - 168 KB] - Amendment 1 [PDF - 107 KB] - Amendment 2 [PDF - 90 KB] - Amendment 3 [PDF - 305 KB] | | Topiramate | Ortho-McNeil-Janssen Pharmaceuticals, Inc. | 7/24/2008 | - Written Request [PDF -280KB] - Amendment 1 [PDF -184KB] | | Trabectedin | Janssen | 6/12/2018 | - Written Request [PDF - 132 KB] | | Trametinib | Novartis | 2/9/2023 | - Written Request [PDF - 257 KB] - Amendment 1 [PDF - 469 KB] - Amendment 2 [PDF - 613 KB] - Amendment 3 [PDF - 513 KB] | | Trofinetide | Acadia Pharmaceuticals Inc. | 2/18/2026 | - Written Request [PDF - 164 KB] | | Valacyclovir | GlaxoSmithKline | 2/28/2008 | - Written Request [PDF -160KB] - Amendment 1 [PDF -167KB] | | Valganciclovir | Hoffman-La Roche Inc. | 7/24/2008 | - Written Request [PDF -266KB] - Amendment 1 [PDF -333 KB] - Amendment 2 [PDF -200 KB] - Amendment 3 [PDF -342 KB] - Amendment 4 [PDF -514 KB] | | Valproate | Abbott | 12/14/2007 | - Written Request [PDF - 69 KB] | | Varenicline | Pfizer | 11/15/2018 | - Written Request [PDF - 266 KB] - Amendment 1 [PDF - 333 KB] - Amendment 2 [PDF - 200 KB] - Amendment 3 [PDF - 342 KB] | | Vigabatrin | Lundbeck | 10/3/2013 | - Written Request [PDF -176 KB] - Amendment 1 [PDF - 366 KB] | | Vilazodone | Allergan | 1/21/2020 | - Written Request [PDF -176KB] - Amendment 1 [PDF - 366KB] | | Vortioxetine | Takeda Pharmaceuticals USA Inc. | 8/21/2023 | - Written Request [PDF - 155 KB] - Amendment 1 [PDF - 304 KB] - Amendment 2 [PDF - 158 KB] | | Zoledronic acid | Novartis | 12/21/2007 | - Written Request [PDF -291 KB] | * Persons with disabilities having problems accessing the PDF files may call (301) 796-3634 for assistance.