BioWorld
www.bioworld.com/articles/480028

Products Not Recommended For Approval By FDA Advisory Panels In 1999

Jan. 1, 2000

CompanyProductDescriptionIndicationAction/Date
Biota Holdings Ltd. (Australia) and Glaxo Wellcome plcRelenzaZanamivir; neuraminidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder formTreatment and prevention of influenza A and BFDA's antiviral drugs advisory committee voted against recommending approval (2/24)
Gilead Sciences-Adefovir dipivoxil 60 mg; reverse transcriptase inhibitorHIV infectionPresented 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 plcLocilex Cream (formerly Cytolex)Pexiganan acetate; topical (1% cream); broad-spectrum anti-infective; synthetic magainin (natural hostdefense peptide isolated from frogs)Infection in diabetic foot ulcersFDA'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 doxorubicinMetastatic breast cancer in combination with cyclophosphamideThe Oncologic Drugs Advisory Committee to the FDA voted against recommending new drug application for approval (9/16)