Glenmark gets approval from US FDA

New Delhi, July 3: Drug major Glenmark Pharmaceuticals Ltd today said it has got green signal from the US Food and Drug Administration (US FDA) for its terbinafine hydrochloride tablets.

The drug is available in the strength of 250 mg (base).

Terbinafine will be the generic equivalent of Novartis's anti-fungal brand Lamisil tablets, a statement said.

The company is manufacturing the finished dose formulation at its manufacturing facility in Goa. Glenmark Pharmaceuticals Inc, US will start marketing the product in the US.

With this approval, GPI now has a portfolio of 19 generic products for the US market and has over 35 Abbreviated New Drug Applications undergoing US FDA nod process, the statement added.

UNI