FDA enforcement letters
Untitled letters from FDA's Office of Prescription Drug Promotion — what the agency actually objected to, in its own words, with the promotional piece it objected to. Public record, shown in full.
2026-08-212 promotional pieces attached
Alar Pharmaceuticals Inc.
ALA-3000 (ketamine pamoate) injection
2026-07-281 promotional piece attached
Travere Therapeutics, Inc.
FILSPARI® (sparsentan) tablets, for oral use
2026-07-152 promotional pieces attached
Sanofi Vaccines US Inc.
BEYFORTUS® (nirsevimab-alip) injection, for intramuscular use
2026-07-13
Viatris Specialty LLC
TOBI® PODHALER® (tobramycin inhalation powder), for oral inhalation use
2026-06-242 promotional pieces attached
Lundbeck Seattle Biopharmaceuticals, Inc.
VYEPTI® (eptinezumab-jjmr) injection, for intravenous use
2026-06-222 promotional pieces attached
Pinnacle Biologics, Inc.
PHOTOFRIN® (porfimer sodium) for injection, for intravenous use
2026-05-261 promotional piece attached
QOL Medical, LLC.
SUCRAID® (sacrosidase) oral solution
2026-05-12
BeOne Medicines USA, Inc.
BRUKINSA® (zanubrutinib) capsules and tablets, for oral use
2026-04-28
Bayer HealthCare Pharmaceuticals, Inc.
NUBEQA® (darolutamide) tablets, for oral use
2026-04-231 promotional piece attached
Alnylam Pharmaceuticals, Inc.
AMVUTTRA® (vutrisiran) injection, for subcutaneous use
2026-04-221 promotional piece attached
Incyte Corporation
NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use
2026-04-081 promotional piece attached
Pfizer, Inc
ADCETRIS® (brentuximab vedotin) for injection, for intravenous use
2026-03-311 promotional piece attached
Amneal Pharmaceuticals LLC
ALYMSYS® (bevacizumab-maly) injection, for intravenous use
2026-03-271 promotional piece attached
BioCorRx Pharmaceuticals Inc.
LUCEMYRA® (lofexidine) tablets, for oral use
2026-02-26
Novo Nordisk Inc.
OZEMPIC® (semaglutide) injection, for subcutaneous use
2026-02-06
Janssen Biotech, Inc.
TREMFYA® (guselkumab) injection, for subcutaneous or intravenous use
2026-02-06
Sobi, Inc.
VONJO® (pacritinib) capsules, for oral use
2026-02-05
Novo Nordisk Inc.
WEGOVY® (semaglutide) tablets, for oral use
2026-01-30
argenx US, Inc.
VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use
2026-01-30
argenx US, Inc.
VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use
2026-01-23
ARS Pharmaceutical Operations, Inc.
NEFFY® (epinephrine nasal spray)
2026-01-071 promotional piece attached
Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)
ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use
2026-01-07
BeOne Medicines USA, Inc.
BRUKINSA® (zanubrutinib) capsules and tablets, for oral use
2025-12-191 promotional piece attached
Esperion Therapeutics, Inc.
NEXLIZET® (bempedoic acid and ezetimibe) tablets, for oral use
2025-12-151 promotional piece attached
BeOne Medicines USA, Inc.
TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use
2025-12-15
Karuna Therapeutics, Inc., a Bristol Myers Squibb Co.
COBENFY™ (xanomeline and trospium chloride) capsules, for oral use
2025-11-24
Daiichi Sankyo, Inc.
TURALIO® (pexidartinib) capsules, for oral use
2025-09-301 promotional piece attached
PharmaTher Inc.
ANDA 217858 KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CII MA 2
2025-09-30
SK Life Science, Inc.
Xcopri® (cenobamate tablets) for oral use, CV
2025-09-23
AstraZeneca
FARXIGA® (dapagliflozin) tablets, for oral use
2025-09-231 promotional piece attached
Novartis Pharmaceuticals Corporation
FABHALTA® ( iptacopan) capsules, for oral use
2025-09-091 promotional piece attached
Aadi Bioscience
FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albuminbound), for intravenous use
2025-09-091 promotional piece attached
AbbVie, Inc.
LINZESS® (linaclotide) capsules, for oral use
2025-09-091 promotional piece attached
AbbVie, Inc.
QULIPTA® (atogepant) tablets, for oral use
2025-09-091 promotional piece attached
AbbVie, Inc.
SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous or intravenous use
2025-09-09
Alexion Pharmaceuticals, Inc.
ULTOMIRIS® (ravulizumab-cwvz) injection, for intravenous use
2025-09-09
Alnylam Pharmaceuticals, Inc.
AMVUTTRA® (vutrisiran) injection, for subcutaneous use
2025-09-091 promotional piece attached
Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)
ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use
2025-09-09
Amgen Inc.
IMDELLTRA™ (tarlatamab-dlle) for injection, for intravenous use
2025-09-09
ARS Pharmaceutical Operations, Inc.
NEFFY® (epinephrine nasal spray)
2025-09-091 promotional piece attached
AstraZeneca Pharmaceuticals LP
FASENRA® (benralizumab) injection, for subcutaneous use
2025-09-09
AstraZeneca Pharmaceuticals LP
FASENRA® (benralizumab) injection, for subcutaneous use
2025-09-09
AstraZeneca Pharmaceuticals LP
FASENRA® (benralizumab) injection, for subcutaneous use
2025-09-09
AstraZeneca Pharmaceuticals LP
TRUQAP® (capivasertib) tablets, for oral use
2025-09-091 promotional piece attached
AstraZeneca Pharmaceuticals LP
CALQUENCE® (acalabrutinib) capsules, for oral use
2025-09-091 promotional piece attached
Axsome Therapeutics, Inc.
AUVELITY® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral use
2025-09-091 promotional piece attached
Azurity Pharmaceuticals, Inc.
DANZITEN (nilotinib) tablets, for oral use
2025-09-091 promotional piece attached
Bausch Health Companies Inc.
JUBLIA® (efinaconazole) topical solution, 10% for topical use
2025-09-09
Boehringer Ingelheim Pharmaceuticals, Inc.
JARDIANCE® (empagliflozin tablets), for oral use
2025-09-09
Boehringer Ingelheim Pharmaceuticals, Inc.
JARDIANCE® (empagliflozin tablets), for oral use
2025-09-09
Boehringer Ingelheim Pharmaceuticals, Inc.
JARDIANCE® (empagliflozin tablets), for oral use
2025-09-091 promotional piece attached
BridgeBio Pharma, Inc.
ATTRUBY® (acoramidis) tablets
2025-09-09
Bristol-Myers Squibb
OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use
2025-09-09
Bristol-Myers Squibb
OPDIVO® (nivolumab) injection, for intravenous use YERVOY® (ipilimumab) injection, for intravenous use
2025-09-091 promotional piece attached
Bristol Myers Squibb
CAMZYOS® (mavacamten) capsules for oral use
2025-09-091 promotional piece attached
Evolus, Inc.
JEUVEAU® (prabotulinumtoxinA-xvfs) for injection, for intramuscular use
2025-09-09
Galderma Laboratories, L.P.
NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use
2025-09-091 promotional piece attached
GlaxoSmithKline LLC
NDA 215499 APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use
2025-09-091 promotional piece attached
Incyte Corporation
PEMAZYRE® (pemigatinib) tablets, for oral use
2025-09-091 promotional piece attached
Ipsen Biopharmaceuticals, Inc.
TAZVERIK® (tazemetostat) tablets, for oral use
2025-09-091 promotional piece attached
Nalpropion Pharmaceuticals, LLC
CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended release tablets, for oral use
2025-09-091 promotional piece attached
Neurocrine Biosciences, Inc
INGREZZA® (valbenazine) capsules, for oral use
2025-09-091 promotional piece attached
Novartis Pharmaceuticals Corporation
KISQALI® (ribociclib) tablets, for oral use
2025-09-091 promotional piece attached
Novartis Pharmaceuticals Corporation
PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use
2025-09-091 promotional piece attached
Novartis Pharmaceuticals Corporation
KESIMPTA® (ofatumumab) injection, for subcutaneous use
2025-09-091 promotional piece attached
Pfizer, Inc.
VELSIPITY™ (etrasimod) tablets, for oral use
2025-09-09
Phathom Pharmaceuticals, Inc.
VOQUEZNA (vonoprazan) tablets, for oral use
2025-09-09
Phathom Pharmaceuticals, Inc.
VOQUEZNA (vonoprazan) tablets, for oral use
2025-09-09
Phathom Pharmaceuticals, Inc.
VOQUEZNA (vonoprazan) tablets, for oral use
2025-09-091 promotional piece attached
Pinnacle Biologics, Inc.
PHOTOFRIN® (porfimer sodium) for injection, for intravenous use
2025-09-091 promotional piece attached
Pinnacle Biologics, Inc.
PHOTOFRIN® (porfimer sodium) for injection, for intravenous use
2025-09-09
Sanofi
TZIELD® (teplizumab-mzwv) injection, for intravenous use
2025-09-091 promotional piece attached
Supernus Pharmaceuticals, Inc.
QELBREE® (viloxazine extended-release capsules), for oral use
2025-09-091 promotional piece attached
Supernus Pharmaceuticals, Inc.
QELBREE® (viloxazine extended-release capsules), for oral use
2025-09-091 promotional piece attached
Takeda Pharmaceuticals America, Inc.
ICLUSIG® (ponatinib) tablets, for oral use
2025-09-091 promotional piece attached
Takeda Pharmaceuticals USA, Inc.
FRUZAQLA® (fruquintinib) capsules, for oral use
2025-09-091 promotional piece attached
Takeda Pharmaceuticals USA, Inc.
FRUZAQLA® (fruquintinib) capsules, for oral use
2025-09-09
Teva Neuroscience, Inc.
AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use
2025-09-09
Teva Neuroscience, Inc.
AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use
2025-09-091 promotional piece attached
UCB, Inc.
BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use
2025-09-091 promotional piece attached
UCB, Inc.
BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use
2025-09-091 promotional piece attached
UCB, Inc.
BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use
2025-09-091 promotional piece attached
UCB, Inc.
RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use
2025-04-281 promotional piece attached
Mayne Pharma LLC
NEXTSTELLIS (drospirenone and estetrol tablets), for oral use
2025-03-211 promotional piece attached
Taiho Oncology, Inc.
NDA 214801, LYTGOBI (futibatinib) tablets, for oral use
2025-02-031 promotional piece attached
Edenbridge DBA Dexcel
NDA 211379, HEMADY (dexamethasone tablets), for oral use
2024-10-311 promotional piece attached
Merz Pharmaceuticals GmbH
BLA 125360 XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use
2024-08-291 promotional piece attached
AbbVie, Inc.
NDA 211765, UBRELVY (ubrogepant) tablets, for oral use
2024-08-011 promotional piece attached
Mirati Therapeutics Inc., a Bristol Myers Squibb Co.
NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use
2024-07-172 promotional pieces attached
Kaleo, Inc.
NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use
2024-01-181 promotional piece attached
Novartis Pharmaceuticals Corporation
NDA 209092 KISQALI (ribociclib) tablets, for oral use
2023-10-311 promotional piece attached
Evofem Biosciences
NDA 208352 PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gel
2023-10-312 promotional pieces attached
Otsuka Pharmaceutical Development and Commercialization, Inc
NDA 205422 REXULTI (brexpiprazole) tablets, for oral use
2023-08-111 promotional piece attached
Exeltis USA Inc.
NDA 211367 SLYND (drospirenone) tablets, oral
2023-06-071 promotional piece attached
Xeris Pharmaceuticals, Inc.
NDA 214133 RECORLEV (levoketoconazole) tablets, oral
2022-06-021 promotional piece attached
Althera Pharmaceuticals
NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral use
2022-03-312 promotional pieces attached
Bausch Health Companies Inc
NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical use
2022-01-191 promotional piece attached
Eli Lilly & Company
BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous use
2021-12-13
Emgality
BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use
2021-08-091 promotional piece attached
Alkindi Sprinkle
NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules
2021-07-071 promotional piece attached
Amgen
BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use
2021-03-08
Biohaven Pharmaceuticals
NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use
2020-11-241 promotional piece attached
Azurity Pharmaceuticals Inc.
NDA 208400 XATMEP® (methotrexate) oral solution
2020-08-14
Xeris Pharmaceuticals, Inc.
NDA 212097 GVOKETM (glucagon) injection, for subcutaneous use
2019-11-181 promotional piece attached
Rockwell Medical, Inc
NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration
2019-11-011 promotional piece attached
Nascent Biotech, Inc.
Pritumumab
2019-09-24
Kowa Pharmaceuticals, Inc.
NDA 022363 Livalo (pitavastatin) tablet, for oral use
2019-07-251 promotional piece attached
CooperSurgical, Inc.
NDA 018680 ParaGard T380A Intrauterine Copper Contraceptive
2019-06-141 promotional piece attached
Aclaris Therapeutics, Inc.
NDA 209305 ESKATA (hydrogen peroxide) topical solution
2019-05-221 promotional piece attached
VIVUS, Inc.
NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV
2019-02-151 promotional piece attached
Phoenix Molecular Imaging Center
Sodium Acetate (C-11)
2018-10-11
Eisai Inc.
NDA 202834; 208277 Fycompa (perampanel) oral suspension, CIII Fycompa(perampanel) tablets, for oral use, CIII
2018-08-161 promotional piece attached
ASCEND Therapeutics US, LLC
NDA 021166 EstroGel 0.06% (estradiol gel) for topical use
2018-06-281 promotional piece attached
Arog Pharmaceuticals, Inc.
Crenolanib besylate
2018-06-19
Pfizer Inc.
NDA 020472 ESTRING® (estradiol vaginal ring)
2018-02-091 promotional piece attached
Collegium Pharmaceuticals, Inc.
NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use
2017-12-281 promotional piece attached
University of California Los Angeles (UCLA)
Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure)