FDA Approves Taro's ANDA for Diflorasone Diacetate Cream

<%=company1%> Inc. (Bramalea, ON, Canada) has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diflorasone Diacetate Cream USP, 0.05%.

Taro's Diflorasone Diacetate Cream is a high-potency topical corticosteroid indicated for the treatment of moderate to severe dermatologic conditions. The cream is bioequivalent to Dermik Laboratories' Psorcon Cream.

This is the second approval this month for Taro. The FDA approved Taro's NDA for over-the-counter Clotrimazole Three-Day Vaginal Cream, 2% earlier this month. The company currently has multiple international regulatory filings and ten ANDAs currently submitted to the FDA.

Taro Pharmaceuticals Inc. is the Canadian subsidiary of Taro Pharmaceutical Industries Ltd. (Herzlia, Israel), a multinational, science-based pharmaceutical company engaged in the discovery, development, manufacturing, and marketing of health care products.

For more information: Taro Pharmaceuticals Inc., 130 East Dr., Bramalea, ON L6T 1C3, Canada. Tel: 905-791-8276. Fax: 905-791-4473.

Edited by Jim Pomager