Taro Pharmaceutical Industries (Nasdaq: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%.
Terconazole vaginal cream is a prescription antifungal medication used for the local treatment of vulvovaginal candidiasis (yeast infections).
Taro's terconazole vaginal cream, 0.4% is bioequivalent to Ortho-McNeil Pharmaceutical's Terazol 7 Vaginal Cream 0.4%. 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 3 Vaginal Cream 0.8%.
As of web-posting, the Taro share was up 1.49% on Wall Street.
Published by Globes [online], Israel business news - www.globes.co.il - on Thursday, January 20, 2005