Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for Voriconazole Tablets, used to treat fungal infections.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the US Food & Drug Administration (USFDA) for Voriconazole Tablets, the therapeutic equivalent to Vfend tablets,” Glenmark said in a BSE filing.
The approval has been granted for tablets in 50 mg and 200 mg strengths.
Citing IMS Health sales data, Glenmark said, for the 12 months to July 2015, Vfend market achieved annual sales of around USD 91.4 million.
The company’s current portfolio consists of 102 products authorised for distribution in the US marketplace and 63 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.
Shares of Glenmark Pharmaceuticals were trading at Rs 1,019.40 apiece in the morning trade on the BSE, down 4.44 per cent from its previous close.