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.
2019-11-181 promotional piece attached
Rockwell Medical, Inc
NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration
2019-11-011 promotional piece attached
Nascent Biotech, Inc.
Pritumumab
2019-09-24
Kowa Pharmaceuticals, Inc.
NDA 022363 Livalo (pitavastatin) tablet, for oral use
2019-07-251 promotional piece attached
CooperSurgical, Inc.
NDA 018680 ParaGard T380A Intrauterine Copper Contraceptive
2019-06-141 promotional piece attached
Aclaris Therapeutics, Inc.
NDA 209305 ESKATA (hydrogen peroxide) topical solution
2019-05-221 promotional piece attached
VIVUS, Inc.
NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV
2019-02-151 promotional piece attached
Phoenix Molecular Imaging Center
Sodium Acetate (C-11)