Generic Lamisil® Tablets and OTC Terbinafine Cream, Approved by the FDA

Filed in archive News , Treatment on July 3, 2007

A product of Novartis, Lamisil® (terbinafine hydrochloride) Tablets is a prescription drug for the treatment of nail fungus infection (onychomycosis).

Now, the FDA has approved the first generic versions of Lamisil® (terbinafine hydrochloride tablets in 250-milligram formulations) from multiple generic drug manufacturers:

• Amneal Pharmaceuticals


• Apotex Corporation


• 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.

In addition, the FDA also approved an application for a generic version of over-the-counter (OTC) Lamisil cream (terbinafine hydrochloride, 1 percent) for the treatment of athlete's foot, manufactured by Taro Pharmaceuticals U.S.A.

Source: FDA News