Company Product Description Indication Action/Date
Biota Holdings Ltd. (Australia) and Glaxo Wellcome plc Relenza Zanamivir; neuraminidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder form Treatment and prevention of influenza A and B FDA's antiviral drugs advisory committee voted against recommending approval (2/24)
Gilead Sciences - Adefovir dipivoxil 60 mg; reverse transcriptase inhibitor HIV infection Presented safety and efficadata to the FDA's antiviral drugs advisory committee, which recommended that the FDA not approve the drug (11/1)
Magainin Pharmaceuticals Inc. and SmithKline Beecham plc Locilex Cream (formerly Cytolex) Pexiganan acetate; topical (1% cream); broad-spectrum anti-infective; synthetic magainin (natural hostdefense peptide isolated from frogs) Infection in diabetic foot ulcers FDA's Anti-Infectives Drug Advisory Committee voted 7-4 against recommending approval (3/4)
The Liposome Co. Inc. Evacet (formerly TLC D-99) Liposomal formulation of doxorubicin Metastatic breast cancer in combination with cyclophosphamide The Oncologic Drugs Advisory Committee to the FDA voted against recommending new drug application for approval (9/16)