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) |
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