Generic OTC Lamisil approved

Executive Summary

FDA on July 2 approves Taro Pharmaceutical U.S.A's application for a generic version of Novartis' OTC athlete's foot cream Lamisil AT (terbinafine hydrochloride, 1 percent). Taro's product will be the first generic Lamisil cream on the market, according to FDA. The firm was granted tentative approval in March 2006 (1"The Tan Sheet" March, 27, 2006, p. 11). Novartis recently introduced a gel form, Lamisil AT Gel Advanced, which "cures most athlete's foot with 1/2 the applications of any other product," according to the product Web site. FDA also approved the first generic versions of Rx Lamisil tablets as the remaining patent or exclusivity for the drug expired June 30...