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