Company

Product

Description

Indication

Action

Cambridge Biotech Corp. (wholly owned subsidiary of bioMerieux Biomedical Corp.)

HIV-1 Western Blot Kit

Urine test used as confirmation of results from Calypte's HIV-1 enzyme immunoassay (EIA)

HIV infection

FDA notified company that product is approv- able (9/18)

Celgene Corp.

Thalomid (was Synovir)

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Erythema nodosum leprosum (ENL), a severe condition associated with leprosy

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee recommended approval for use in treating cutaneous but not systemic ENL (9/5); FDA sent company an approvable letter (9/22)

Cephalon Inc.

Provigil

Modafinal; Alpha adrenergic receptor specific drug that promotes wakefulness

Narcolepsy and idiopathic hypersomnia

FDA sent company an approvable letter (12/30)

Pharmos Corp. and Bausch & Lomb Pharmaceuticals Inc. (NYSE:BOL)

Lotemax

Loteprodnol etabonate ophthalmic suspension 0.5% (topical steroid)

Treatment of ophthalmic inflammation

FDA sent company an approvable letter (9/5)


No Comments