Glenmark's anti-fungal drug gets USFDA nod

Glenmark Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA)  for its Abbreviated New Drug Application (ANDA) for terbinafine hydochloride 250 mg oral tablets.

It is the generic equivalent of Novartis's anti-fungal drug Lamisil tablets with annual sales of over $650 million (IMS-Dec-2006) in the US, the company informed the Bombay Stock Exchange in a statement.

It manufactures the finished dose formulation at its USFDA approved manufacturing facility in Goa. The company's US subsidiary, Glenmark Pharmaceuticals, USA (GPI) will start marketing the product in the US upon patent expiry on June 30, 2007.

With this approval, GPI now has a portfolio of 16 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process.