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USFDA approves Glenmark Pharma to market drug for relapsing multiple sclerosis

Glenmark Pharma has been granted final approval by the United States Food and Drug Administration (USFDA) for Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg. They are used for the treatment of relapsing forms of multiple sclerosis in adults. This is the most common form of multiple sclerosis.

About 75% to 85% of people with multiple sclerosis are initially diagnosed with relapsing forms of multiple sclerosis. People with RRMS have temporary periods called relapses, flare-ups or exacerbations, when new symptoms appear. Glenmark said Tecfidera delayed-release capsules achieved annual sales of approximately USD 3.8 billion in the market. Glenmark Pharmaceuticals NSE -0.36 % Inc., USA, said that current portfolio consists of 164 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications are pending approval with the USFDA.


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