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Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA for the sale of Tretinoin capsules, used in the treatment of leukemia.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Tretinoin capsules, 10 mg,” the company said in a BSE filing.
The approved product is a generic version of Vesanoid capsules, 10 mg, of Hoffmann La Roche, Inc. (which is no longer being marketed in the US), the company added.
According to IMS Health sales data for the 12 months to October 2016, Glenmark said the Vesanoid capsules, 10 mg market, achieved annual sales of approximately $22.0 million.
The company’s current portfolio consists of 112 products authorised for distribution in the US marketplace and 63 ANDA pending approval with the USFDA.
Shares of Glenmark Pharmaceuticals were trading up by 0.65 per cent at Rs 894.85 on the BSE.
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