All Clarivate Analytics websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.
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)
