July 2, 2007 -- The FDA today approved the first generic versions of prescription Lamisil tablets to treat nail fungus infection and a generic version of Lamisil cream to be sold as an over-the-counter athlete's foot treatment.
Lamisil is terbinafine hydrochloride. Its patent expired on June 30, 2007.
The FDA approved applications from multiple generic drugmakers for generic versions of Lamisil tablets in 250-milligram formulations as a treatment for nail fungus. Such infections occur when fungi invade a fingernail or toenail, or the skin underneath the nail.
"This approval offers Americans additional alternatives when choosing medications to treat nail fungus infections," says Gary J. Buehler, RPh, in an FDA news release. Buehler directs the FDA's Office of Generic Drugs.
Lamisil tablets are usually taken for six to 12 weeks for nail infections. Lamisil is not appropriate for people with liver and kidney disease. Patients may be asked to get lab tests during that time to rule out rare liver and blood side effects. More common side effects may include headache, diarrhea, and upset stomach.
Today's FDA announcement doesn't mention side effects specific to generic versions of Lamisil.
The FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride, 1%) to treat athlete's foot, a skin disease caused by a fungus that usually occurs between the toes.
Companies making the approved generic versions of Lamisil include Amneal Pharmaceuticals, Apotex, Aurobindo Pharma USA, Dr. Reddy’s Laboratories, Gedeon Richter USA, Genpharm, Glenmark Pharmaceuticals, InvaGen Pharmaceuticals, Mylan Pharmaceuticals, Orgenus Pharma, Roxane Laboratories, TEVA Pharmaceuticals USA, Watson Laboratories, and Wockhardt USA.
The generic version of Lamisil cream is made by Taro Pharmaceuticals USA.