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Article: Taro Receives FDA Approval for Alclometasone Dipropionate Ointment USP, 0.05% ANDA; Generic Equivalent to Aclovate Ointment.
- Article from:
- Business Wire
- Article date:
- July 30, 2004
CopyrightCOPYRIGHT 2004 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today 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(R) 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(R) ointment were approximately $2.5 million in 2003, according to industry sources.
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