New Delhi : Glenmark Pharmaceuticals has received final approval from the US health regulator for generic Diclofenac Sodium gel used for treatment of skin lesion.
“Glenmark Pharmaceuticals Inc USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Diclofenac Sodium gel, 3 per cent,” the company said in a BSE filing.
The product is generic version of Fougera Pharmaceuticals Inc’s Solaraze gel, 3 per cent, it added.
“According to IMS Health sales data for the 12 month period ending July 2016, the Solaraze Gel, 3 per cent and all available therapeutic equivalents market achieved annual sales of approximately USD 297.9 million,” Glenmark said.
Solaraze (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses.
The company’s current portfolio consists of 110 products authorised for distribution in the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were today trading at Rs 884 per scrip on BSE, up 1.02 per cent from its previous close.