USFDA gives final nod to Glenmark Pharma for anti-herpes drug

New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for Acyclovir Ointment used for treatment of herpes virus.

"Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Acyclovir Ointment USP, 5 per cent, the generic version of Zovirax Ointment, 5 per cent, of Valeant International Bermuda," Glenmark Pharmaceuticals said in a BSE filing.

According to IMS Health sales data for the 12 months to June 2017, Zovirax Ointment achieved annual sales of approximately USD 110.3 million, Glenmark said.

The company's current portfolio consists of 121 products authorised for distribution in the US marketplace and 64 Abbreviated New Drug Applications (ANDA) pending approval with the regulator.