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.
2018-10-11
Eisai Inc.
NDA 202834; 208277 Fycompa (perampanel) oral suspension, CIII Fycompa(perampanel) tablets, for oral use, CIII
2018-08-161 promotional piece attached
ASCEND Therapeutics US, LLC
NDA 021166 EstroGel 0.06% (estradiol gel) for topical use
2018-06-281 promotional piece attached
Arog Pharmaceuticals, Inc.
Crenolanib besylate
2018-06-19
Pfizer Inc.
NDA 020472 ESTRING® (estradiol vaginal ring)
2018-02-091 promotional piece attached
Collegium Pharmaceuticals, Inc.
NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use