FDA Approves First Generic Versions of Lamisil Tablets

The U.S. Food and Drug Administration today approved the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). 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,” said Gary J. Buehler, R.Ph., director of FDA’s Office of Generic Drugs.

FDA approved applications from multiple 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 remaining patent or exclusivity for Lamisil expired on June 30, 2007.

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, FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride,1 percent) to treat athlete’s foot, a skin disease caused by a fungus that usually occurs between the toes. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.

The FDA’s Office of Generic Drugs ensures that generic drugs are safe and effective through a thorough scientific and regulatory process.

For more information:
Office of Generic Drugs
www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

Generic Drugs: What You Need to Know
www.fda.gov/fdac/features/2002/502_generic.html.

FDA monthly reports for first-time generics
www.fda.gov/cder/ogd/approvals/