"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 drug major said in a filing to BSE.
Drug major Glenmark Pharmaceuticals on Friday said it has received final nod from the health regulator for Fingolimod capsules. 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 drug major said in a filing to BSE.
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 USD 2.1 billion, the company said.
Glenmark's current portfolio consists of 164 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications pending approval with the USFDA.
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