Office of Prescription Drug Promotion Untitled Letters

Untitled Letters These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information. 1997-2016 Compliance Actions are archived. To view them, please see the FDA Archive. To view OPDP Warning Letters, please see Warning Letters. Office of Prescription Drug Promotion Untitled Letters and Corresponding Promotional Communications | Issued Date | Company / Individual | Product / Issue | Response Letter | Close-Out Letter | |---|---|---|---|---| | 2/26/2026 | Novo Nordisk Inc. - Untitled Letter (PDF) | OZEMPIC® (semaglutide) injection, for subcutaneous use | || | 2/6/2026 | Janssen Biotech, Inc. - Untitled Letter (PDF) | TREMFYA® (guselkumab) injection, for subcutaneous or intravenous use | || | 2/6/2026 | Sobi, Inc. - Untitled Letter (PDF) | VONJO® (pacritinib) capsules, for oral use | Close-Out Letter (PDF) | | | 2/5/2026 | Novo Nordisk Inc. - Untitled Letter (PDF) | WEGOVY® (semaglutide) tablets, for oral use | || | 1/30/2026 | argenx US, Inc. - Untitled Letter (PDF) | VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use | || | 1/30/2026 | argenx US, Inc. - Untitled Letter (PDF) | VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use | || | 1/23/2026 | ARS Pharmaceutical Operations, Inc. - Untitled Letter (PDF) | NEFFY® (epinephrine nasal spray) | None | | | 1/7/2026 | Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.) - Untitled Letter (PDF) - Promotional Material (PDF) | ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use | None | Close-Out Letter (PDF) | | 1/7/2026 | BeOne Medicines USA, Inc. - Untitled Letter (PDF) | BRUKINSA® (zanubrutinib) capsules and tablets, for oral use | None | Close-Out Letter (PDF) | | 12/19/2025 | Esperion Therapeutics, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NEXLIZET® (bempedoic acid and ezetimibe) tablets, for oral use | None | Close-Out Letter (PDF) | | 12/15/2025 | BeOne Medicines USA, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use | None | Close-Out Letter (PDF) | | 12/15/2025 | Karuna Therapeutics, Inc., a Bristol Myers Squibb Co. - Untitled Letter (PDF) | COBENFY™ (xanomeline and trospium chloride) capsules, for oral use | None | | | 11/24/2025 | Daiichi Sankyo, Inc. - Untitled Letter (PDF) | TURALIO® (pexidartinib) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | GlaxoSmithKline LLC - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 215499 APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use | None | Close-Out Letter (PDF) | | 9/30/2025 | SK Life Science, Inc. - Untitled Letter (PDF) | Xcopri® (cenobamate tablets) for oral use, CV | None | Close-Out Letter (PDF) | | 9/30/2025 | PharmaTher Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | ANDA 217858 KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CII MA 2 | None | Close-Out Letter (PDF) | | 9/23/2025 | AstraZeneca - Untitled Letter (PDF) | FARXIGA® (dapagliflozin) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Aadi Bioscience - Untitled Letter (PDF) - Promotional Material (PDF) | FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albuminbound), for intravenous use | None | Close-Out Letter (PDF) | | 9/23/2025 | Novartis Pharmaceuticals Corporation - Untitled Letter (PDF) - Promotional Material (PDF) | FABHALTA® (iptacopan) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.) - Untitled Letter (PDF) - Promotional Material (PDF) | ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use | None | Close-Out Letter (PDF) | | 9/9/2025 | Takeda Pharmaceuticals America, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | ICLUSIG® (ponatinib) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Amgen Inc. - Untitled Letter (PDF) | IMDELLTRA™ (tarlatamab-dlle) for injection, for intravenous use | None | | | 9/9/2025 | Evolus, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | JEUVEAU® (prabotulinumtoxinA-xvfs) for injection, for intramuscular use | None | Close-Out Letter (PDF) | | 9/9/2025 | Incyte Corporation - Untitled Letter (PDF) - Promotional Material (PDF) | PEMAZYRE® (pemigatinib) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Pinnacle Biologics, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | PHOTOFRIN® (porfimer sodium) for injection, for intravenous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Pinnacle Biologics, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | PHOTOFRIN® (porfimer sodium) for injection, for intravenous use | None | Close-Out Letter (PDF) | | 9/9/2025 | UCB, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use | None | | | 9/9/2025 | AbbVie, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous or intravenous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Ipsen Biopharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | TAZVERIK® (tazemetostat) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Alnylam Pharmaceuticals, Inc. - Untitled Letter (PDF) | AMVUTTRA® (vutrisiran) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | BridgeBio Pharma, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | ATTRUBY® (acoramidis) tablets | None | Close-Out Letter (PDF) | | 9/9/2025 | Teva Neuroscience, Inc. - Untitled Letter (PDF) | AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Teva Neuroscience, Inc. - Untitled Letter (PDF) | AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Axsome Therapeutics, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | AUVELITY® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | UCB, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | UCB, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | UCB, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | AstraZeneca Pharmaceuticals LP - Untitled Letter (PDF) - Promotional Material (PDF) | CALQUENCE® (acalabrutinib) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Bristol Myers Squibb - Untitled Letter (PDF) - Promotional Material (PDF) | CAMZYOS® (mavacamten) capsules for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Nalpropion Pharmaceuticals, LLC - Untitled Letter (PDF) - Promotional Material (PDF) | CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended release tablets, for oral use | None | | | 9/9/2025 | Azurity Pharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | DANZITEN (nilotinib) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | AstraZeneca Pharmaceuticals LP - Untitled Letter (PDF) - Promotional Material (PDF) | FASENRA® (benralizumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | AstraZeneca Pharmaceuticals LP - Untitled Letter (PDF) | FASENRA® (benralizumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | AstraZeneca Pharmaceuticals LP - Untitled Letter (PDF) | FASENRA® (benralizumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Takeda Pharmaceuticals USA, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | FRUZAQLA® (fruquintinib) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Takeda Pharmaceuticals USA, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | FRUZAQLA® (fruquintinib) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Neurocrine Biosciences, Inc - Untitled Letter (PDF) - Promotional Material (PDF) | INGREZZA® (valbenazine) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Novartis Pharmaceuticals Corporation - Untitled Letter (PDF) - Promotional Material (PDF) | KESIMPTA® (ofatumumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Boehringer Ingelheim Pharmaceuticals, Inc. - Untitled Letter (PDF) | JARDIANCE® (empagliflozin tablets), for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Boehringer Ingelheim Pharmaceuticals, Inc. - Untitled Letter (PDF) | JARDIANCE® (empagliflozin tablets), for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Boehringer Ingelheim Pharmaceuticals, Inc. - Untitled Letter (PDF) | JARDIANCE® (empagliflozin tablets), for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Bausch Health Companies Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | JUBLIA® (efinaconazole) topical solution, 10% for topical use | None | Close-Out Letter (PDF) | | 9/9/2025 | Novartis Pharmaceuticals Corporation - Untitled Letter (PDF) - Promotional Material (PDF) | KISQALI® (ribociclib) tablets, for oral use | None | | | 9/9/2025 | AbbVie, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | LINZESS® (linaclotide) capsules, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | ARS Pharmaceutical Operations, Inc. - Untitled Letter (PDF) | NEFFY® (epinephrine nasal spray) | None | | | 9/9/2025 | Galderma Laboratories, L.P. - Untitled Letter (PDF) | NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Bristol-Myers Squibb - Untitled Letter (PDF) | OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Bristol-Myers Squibb - Untitled Letter (PDF) | OPDIVO® (nivolumab) injection, for intravenous use YERVOY® (ipilimumab) injection, for intravenous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Supernus Pharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | QELBREE® (viloxazine extended-release capsules), for oral use | None | | | 9/9/2025 | Supernus Pharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | QELBREE® (viloxazine extended-release capsules), for oral use | None | | | 9/9/2025 | AbbVie, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | QULIPTA® (atogepant) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Novartis Pharmaceuticals Corporation - Untitled Letter (PDF) - Promotional Material (PDF) | PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use | None | Close-Out Letter (PDF) | | 9/9/2025 | AstraZeneca Pharmaceuticals LP - Untitled Letter (PDF) | TRUQAP® (capivasertib) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Sanofi - Untitled Letter (PDF) | TZIELD® (teplizumab-mzwv) injection, for intravenous use | None | Close-Out Letter (PDF) | | 9/9/2025 | Pfizer, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | VELSIPITY™ (etrasimod) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Phathom Pharmaceuticals, Inc. - Untitled Letter (PDF) | VOQUEZNA (vonoprazan) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Phathom Pharmaceuticals, Inc. - Untitled Letter (PDF) | VOQUEZNA (vonoprazan) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Phathom Pharmaceuticals, Inc. - Untitled Letter (PDF) | VOQUEZNA (vonoprazan) tablets, for oral use | None | Close-Out Letter (PDF) | | 9/9/2025 | Alexion Pharmaceuticals, Inc. - Untitled Letter (PDF) | ULTOMIRIS® (ravulizumab-cwvz) injection, for intravenous use | None | | | 4/28/2025 | Mayne Pharma LLC - Untitled Letter (PDF) - Promotional Material (PDF) | NEXTSTELLIS (drospirenone and estetrol tablets), for oral use | None | Close-Out Letter (PDF) | | 3/21/2025 | Taiho Oncology, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 214801, LYTGOBI (futibatinib) tablets, for oral use | None | Close-Out Letter (PDF) | | 2/3/2025 | Edenbridge DBA Dexcel - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 211379, HEMADY (dexamethasone tablets), for oral use | None | Close-Out Letter (PDF) | | 10/31/2024 | Merz Pharmaceuticals GmbH - Untitled Letter (PDF) - Promotional Material (MP4 | Duration: 1min 14sec ) | BLA 125360 XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use | None | Close-Out Letter (PDF) | | 8/29/2024 | AbbVie, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 211765, UBRELVY (ubrogepant) tablets, for oral use | None | Close-Out Letter (PDF) | | 8/1/2024 | Mirati Therapeutics Inc., a Bristol Myers Squibb Co. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use | None | Close-Out Letter (PDF) | | 7/17/2024 | Kaleo, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) - Promotional Material (MP4 | Duration: 40sec) | NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use | None | Close-Out Letter (PDF) | | 1/18/2024 | Novartis Pharmaceuticals Corporation - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 209092 KISQALI (ribociclib) tablets, for oral use | None | Close-Out Letter (PDF) | | 10/31/2023 | Otsuka Pharmaceutical Development and Commercialization, Inc - Untitled Letter (PDF) - Promotional Material (PDF) - Promotional Material (PDF) | NDA 205422 REXULTI (brexpiprazole) tablets, for oral use | None | Close-Out Letter (PDF) | | 10/31/2023 | Evofem Biosciences - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 208352 PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gel | None | Close-Out Letter (PDF) | | 6/07/2023 | Xeris Pharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 214133 RECORLEV (levoketoconazole) tablets, oral | None | Close-Out Letter (PDF) | | 8/11/2023 | Exeltis USA Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 211367 SLYND (drospirenone) tablets, oral | None | Close-Out Letter (PDF) | | 01/19/2022 | Eli Lilly & Company - Untitled Letter (PDF) - Promotional Material (PDF) | BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 3/31/2022 | Bausch Health Companies Inc - Untitled Letter (PDF) - Promotional Material (PDF) - Promotional Material (PDF) | NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical use | None | Close-Out Letter (PDF) | | 6/02/2022 | Althera Pharmaceuticals - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral use | None | Close-Out Letter (PDF) | | 12/13/2021 | Emgality - Untitled Letter (PDF) | BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use | Response Letter (PDF) | Close-Out Letter (PDF) | | 8/09/2021 | Alkindi Sprinkle - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules | None | Close-Out Letter (PDF) | | 7/07/2021 | Amgen - Untitled Letter (PDF) - Promotional Material (PDF) | BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use | None | Close-Out Letter (PDF) | | 3/08/2021 | Biohaven Pharmaceuticals - Untitled Letter (PDF) | NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use | None | Close-Out Letter (PDF) | | 11/24/2020 | Azurity Pharmaceuticals Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 208400 XATMEP® (methotrexate) oral solution | None | None | | 8/14/2020 | Xeris Pharmaceuticals, Inc. - Untitled Letter (PDF) | NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use | None | None | | 11/18/2019 | Rockwell Medical, Inc - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration | None | None | | 11/01/2019 | Nascent Biotech, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | Pritumumab | None | None | | 9/24/2019 | Kowa Pharmaceuticals, Inc. - Untitled Letter (PDF) | NDA 022363 Livalo (pitavastatin) tablet, for oral use | None | None | | 7/25/2019 | CooperSurgical, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 018680 ParaGard T380A Intrauterine Copper Contraceptive | None | None | | 6/14/2019 | Aclaris Therapeutics, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 209305 ESKATA (hydrogen peroxide) topical solution | None | None | | 5/22/2019 | VIVUS, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV | None | None | | 2/15/2019 | Phoenix Molecular Imaging Center - Untitled Letter (PDF) - Promotional Material (PDF) | Sodium Acetate (C-11) | None | None | | 10/11/2018 | Eisai Inc. - Untitled Letter (PDF) | - NDA 202834; 208277 - Fycompa (perampanel) oral suspension, CIII - Fycompa(perampanel) tablets, for oral use, CIII | None | None | | 8/16/2018 | ASCEND Therapeutics US, LLC - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 021166 EstroGel 0.06% (estradiol gel) for topical use | None | None | | 6/28/2018 | Arog Pharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | Crenolanib besylate | None | None | | 6/19/2018 | Pfizer Inc. - Untitled Letter (PDF) | NDA 020472 ESTRING® (estradiol vaginal ring) | None | None | | 2/09/2018 | Collegium Pharmaceuticals, Inc. - Untitled Letter (PDF) - Promotional Material (PDF) | NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use | None | None | | 12/28/2017 | University of California Los Angeles (UCLA) - Untitled Letter (PDF) - Promotional Material (PDF) | Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure) | None | None | | 5/18/2017 | Orexigen Therapeutics, Inc. | NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets | None | None |