The approved product is a generic version of Vesanoid capsules, 10 mg, of Hoffmann La Roche
Glenmark Pharmaceuticals has received final approval from the US health regulator US FDA for the sale of Tretinoin capsules, used in the treatment of leukemia.
“Glenmark Pharmaceuticals, USA has been granted final approval by the United States Food & Drug Administration (US FDA) 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 (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 FDA.