Glenmark Gets Tentative U.S. FDA Nod For Generic Multiple Sclerosis Treatment Drug
An Ascophenum-P tablet sits before packaging at OAO Pharmstandard’s Leksredstva drug manufacturing unit in Kursk, Russia. (Photographer: Andrey Rudakov/Bloomberg)

Glenmark Gets Tentative U.S. FDA Nod For Generic Multiple Sclerosis Treatment Drug

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Glenmark Pharmaceuticals Ltd. on Wednesday said it has received tentative nod from the U.S. health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis.

The tentative nod granted by U.S. Food & Drug Administration to Glenmark Pharmaceuticals Inc, USA is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg.

These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement. Citing IQVIATM sales data for the 12 month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately $ 3.7 billion.

Glenmark's said its current portfolio consists of 161 products authorised for distribution in the U.S. market and 49 abbreviated new drug applications pending approval with the U.S. FDA.

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