Glenmark receives US FDA approval for its new drug

Mumbai, June 21 (UNI) City-based pharma major Glenmark Pharmaceuticals announced it has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250 mg oral tablets.

It is the AB-rated generic equivalent of Novartis's anti-fungal Lamisil tablets. Glenmark is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa.

Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc. USA will start marketing the product in the US upon patent expiry on June 30 this year.

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

UNI