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www.fdanews.com/articles/67805-taro-wins-us-fda-approval-for-ortho-mcneil-generic

TARO WINS US FDA APPROVAL FOR ORTHO-McNEIL GENERIC

January 21, 2005

Israeli drugmaker Taro has reportedly received FDA approval for its 0.4% terconazole vaginal cream, indicated for vulvovaginal candidiasis. The product is bioequivalent to US healthcare company Ortho-McNeil's Terazol product, on which sales were some US$42mn in the 12 months to end September 2004. The US FDA approved Taro's ANDA for a stronger 0.8% Terazol equivalent in April 2004.