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Article: Taro Receives Approval for Terconazole Vaginal Cream, 0.4% ANDA; Generic Equivalent to Terazol-R- 7 Vaginal Cream.
- Article from:
- Business Wire
- Article date:
- January 20, 2005
CopyrightCOPYRIGHT 2005 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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HAWTHORNE, N.Y. -- 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 ...