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.
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