US FDA approves generic Lamisil

The US Food and Drug Administration has approved the first generic versions of Swiss drug major Novartis' Lamisil (terbinafine HCl), an oral drug used to treat nail fungus infection (onychomycosis).

The FDA approved applications from multiple generic drug manufacturers for terbinafine HCl tablets in 250mg formulations. Manufacturers include: Amneal Pharmaceuticals, Apotex, Aurobindo, Dr Reddy's Laboratories, Richter Gedeon, Genpharm, Glenmark Pharmaceuticals, InvaGen Pharmaceuticals, Mylan, Orgenus Pharma, Roxane Laboratories, Teva and Watson Laboratories.

The remaining patent exclusivity for Lamisil expired on June 30. According to the on-line trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the USA.