Company

Product

Description

Indication

Ruling

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)


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