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)