FDA Approves Generic Versions of Lamisil

Patent expires on Lamisil to treat onychomycosis and athlete's foot

FRIDAY, July 6 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval to several manufacturers to produce generic versions of Lamisil (terbinafine hydrochloride), a prescription drug sold in tablet form to treat nail fungus infections and as an over-the-counter cream to treat athlete's foot. The patent for Lamisil expired on June 30.

Several companies were granted approval to produce 250-mg terbinafine hydrochloride pills for the treatment of onychomycosis, including 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., and Wockhardt USA Inc.

Taro Pharmaceuticals USA Inc. was granted a license to produce 1 percent terbinafine hydrochloride cream.

"This approval offers Americans additional alternatives when choosing medications to treat nail fungus infections," said Gary J. Buehler, R.Ph., director of FDA's Office of Generic Drugs, in a statement.

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