FDA approves Taro Pharmaceutical Industries' Fluorouracil Topical Cream ANDA

Taro Pharmaceutical Industries Ltd. (“Taro” or the “Company,” Pink Sheets: TAROF) today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (“ANDA”) for Fluorouracil Topical Cream USP, 5% (“fluorouracil cream”).

Taro’s fluorouracil cream is a prescription pharmaceutical product used for topical treatment of multiple actinic or solar keratoses and superficial basal cell carcinomas, and is bioequivalent to Efudex® Topical Cream 5% of Valeant Pharmaceuticals International. According to industry sources, Efudex® Topical Cream 5% had annual U.S. sales in 2009 of approximately $70 million.