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.
Taro Pharmaceutical Industries Ltd.