BioWorld
www.bioworld.com/articles/484501

Products Ruled Not Approvable By FDA

Jan. 1, 1998

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)