The FDA today approved the first generic versions of Novartis' Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis).
The agency approved applications from multiple generic drug manufacturers for terbinafine hydrochloride tablets in 250-milligram formulations. Those generic manufacturers 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.
Patent exclusivity for Lamisil expired on June 30.
Lamisil tablets are the 57th-best selling brand-name prescription drug in the US, the FDA said.
In addition to terbinafine tablets, FDA also approved an application for a generic version of OTC Lamisil cream (terbinafine hydrochloride,1%) to treat athlete’s foot. The cream is manufactured by Taro Pharmaceuticals USA.