FDA approves generic Lamisil

WASHINGTON, July 2 (UPI) -- The U.S. Food and Drug Administration has approved the first generic versions of Lamisil (terbinafine hydrochloride) tablets to treat nail fungus infection.

"This approval offers Americans additional alternatives when choosing medications to treat nail fungus infections," Gary Buehler, director of the FDA's Office of Generic Drugs said Monday.

The FDA approved applications from several generic drug manufacturers for terbinafine hydrochloride tablets in 250-milligram formulations. Manufacturers include: Amneal Pharmaceuticals, Apotex Corp., Aurobindo Pharma USA Inc., Dr. Reddy's Laboratories Ltd., Gedeon Richter USA Inc., Genpharm Inc., Glenmark Pharmaceuticals Inc., InvaGen Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Orgenus Pharma Inc., Roxane Laboratories Inc., TEVA Pharmaceuticals USA, Watson Laboratories Inc., Wockhardt USA Inc.

The patent or exclusivity for Lamisil expired June 30.

According to the online trade magazine Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the United States.

In addition to terbinafine tablets, the FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride, 1 percent) to treat athlete's foot. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.