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.
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