Glenmark gets final USFDA nod for Fingolimod capsules

Glenmark′s current portfolio consists of 164 products authorised for distribution in the American market.

Mumbai based drug major Glenmark Pharmaceutical said its US subsidiary has received final nod from the US health regulator to market Fingolimod capsules in the American market. The capsules are used in the treatment of adult patients with relapsing forms of multiple sclerosis.

Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation," the company said in a statement.

According to IQVIA sales data for the 12-month period ending April 2020, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately $2.1 billion, it added.

Glenmark′s current portfolio consists of 164 products authorised for distribution in the US marketplace and 44 ANDA′s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.