Glenmark Pharmaceuticals has been granted a final approval from the US Food and Drug Administration (USFDA) for sale of Tretinoin Capsules, used in treatment of leukemia.
"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US health regulator) for Tretinoin Capsules, 10 mg," the company said in a filing to the BSE.
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 US regulator.
At 11:52 a.m., shares in Glenmark were trading 0.84 per cent higher at Rs. 896.60 apiece on the BSE, whose benchmark Sensex index was up 0.45 per cent.
PTI inputs
