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.
2021-12-13
Emgality
BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use
2021-08-091 promotional piece attached
Alkindi Sprinkle
NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules
2021-07-071 promotional piece attached
Amgen
BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use
2021-03-08
Biohaven Pharmaceuticals
NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use