FDAnews
www.fdanews.com/articles/95426-fda-approves-first-generic-versions-of-lamisil-tablets

FDA Approves First Generic Versions of Lamisil Tablets

July 3, 2007

The FDA announced it approved the first generic versions of prescription Lamisil tablets, a treatment of nail fungus infection.

The FDA said it approved applications from multiple generic drug manufacturers, including: Amneal Pharmaceuticals, Apotex, Aurobindo Pharma, 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 remaining patent or exclusivity for Lamisil expired June 30, the agency said.

According to the online trade magazine, Drug Topics, Lamisil is the 57th highest selling brand-name prescription drug by retail dollars in the U.S.