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.
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