Oral transmucosal fentanyl citrate
Treatment of breakthrough pain in cancer patients with chronic pain
FDA sent company a not approvable letter, citing issues related to clinical results, data analysis, manufacturing and proposed risk management plan (11/14)
Cor Therapeutics Inc.
Small molecule compound (derived from rattlesnake venom) that inhibits GPIIb/IIIa receptor that mediates platelet aggregation
To reduce death, heart attack and other complications of percutaneous transluminal coronary angioplasty (as adjunct therapy)
FDA sent company a not approvable letter (3/25); company submitted amendment to NDA that includes data from Phase III PURSUIT trial (10/20)
Gilead Sciences Inc.
Cidofovir gel; nucleotide analogue that inhibits viral replication
Treatment of refractory herpes simplex virus infection in AIDS patients
FDA determined that Phase I/II data were not sufficient to grant marketing clearance (5/6)