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Generic Drugs
U.S. FDA grants approval for generic antifungal vaginal cream
February 20th, 2005
Taro Pharmaceutical Industries Ltd. (TARO) and its affiliates and subsidiaries reported 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 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. ...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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