Anesta Corp. | ACTIQ | 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. | Integrilin | 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. | Forvade | 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) |