Glenmark gets USFDA nod for anti-fungal drug

Mumbai, July 3 (UNI) Glenmark Pharmaceuticals Ltd today announced that it has received a final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Terbinafine Hydrochloride Tablets, 250 mg (base).

In a communication to the Bombay Stock Exchange (BSE), Glenmark said Terbinafine Hydrochloride Tablets, 250 mg (base) is the AB-rated generic equivalent of Novartis' anti-fungal Lamisil tablets with annual sales of over US Dollar 650 mn (IMS-Dec 2006) in the US.

The company is manufacturing the finished dosage formulations at its USFDA-approved manufacturing facility in Goa. The company's US subsidiary, Glenmark Pharmaceuticals Inc. will start marketing the product in the US.

With this approval, Glenmark Pharmaceuticals Inc. now has a portfolio of 19 generic products for the US market and has over 35 ANDAs undergoing USFDA approval process and launch, the company said.

UNI