Glenmark gets USFDA approval for skin lesion treatment gel

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Mumbai, Sep 14 (IANS) Glenmark Pharmaceuticals said on Wednesday it has received approval from the United States Food and Drug Administration (USFDA) for Diclofenac Sodium gel used for treatment of skin lesions.

“Glenmark Pharmaceuticals Inc USA has been granted final approval by the USFDA for Diclofenac Sodium gel, 3 per cent, the generic version of Solaraze gel, 3 per cent,” the company said in a BSE filing.

“According to IMS Health sales data for the 12-month period ending July 2016, the Solaraze Gel, 3 per cent market achieved annual sales of approximately $297.9 million,” it said.

Glenmark’s current portfolio consists of 110 products authorised for distribution in the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) are pending for approval with the USFDA.

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