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Generic Terazol Cream Receives FDA Approval
Taro's terconazole vaginal cream, 0.8% is bioequivalent to Ortho-McNeil Pharmaceutical's Terazol® 3 Vaginal Cream 0.8%. Terconazole 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 $27.5 million in 2003.
"Taro has developed a range of generic antifungal pharmaceutical products since 1993," said Barrie Levitt, M.D., Chairman of the Company. "In addition, we have been an innovator in this category with the FDA approval of Taro's New Drug Application ("NDA") for our Clotrimazole 3-Day Vaginal Cream product."
Currently, Taro has 32 filings at the FDA: 31 ANDAs, including tentative approvals for fluconazole tablets and loratadine syrup, plus an NDA related to the Company's proprietary NonSpil(TM) liquid drug delivery system. In addition, the Company has regulatory filings in Canada, Israel and other countries.
Source: Taro Pharmaceutical Industries Ltd.