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.
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