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Drug Development
U.S. FDA approves new drug application for generic topical cortisone ointment
September 5th, 2004
Taro Pharmaceutical Industries Ltd. (TARO) reported that its U.S. affiliate has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Alclometasone Dipropionate Ointment, USP 0.05% (alclometasone ointment). Taro's alclometasone ointment is bioequivalent to GlaxoSmithKline's Aclovate ointment, a low- to medium-potency topical corticosteroid product. Alclometasone ointment, a prescription product, is used for the treatment of inflammatory skin diseases. U.S. sales of Aclovate ointment were approximately $2.5 million in 2003, according to industry sources. Taro manufactures and markets a...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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