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Friday 20 January 2006
Taro Receives Approval for Terconazole Vaginal Cream, 0.4% ANDA; Generic Equivalent to Terazol-R- 7 Vaginal Cream
Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) and its affiliates and subsidiaries ("Taro") reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for terconazole vaginal cream, 0.4%.
Taro's terconazole vaginal cream, 0.4% is bioequivalent to Ortho-McNeil Pharmaceutical's Terazol(R) 7 Vaginal Cream 0.4%. Terconazole vaginal cream is a prescription antifungal medication used for the local treatment of vulvovaginal candidiasis (yeast infections). According to industry sources, the Ortho-McNeil product had U.S. sales of approximately $42 million for the 12 months ending September 30, 2004.
In April 2004, Taro also received FDA approval of its ANDA for terconazole vaginal cream, 0.8%, bioequivalent to Ortho-McNeil Pharmaceutical's Terazol(R) 3 Vaginal Cream 0.8%.