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Glenmark gets tentative USFDA nod for generic version of Tecfidera Capsules


Glenmark gets tentative USFDA nod for generic version of Tecfidera Capsules

“According to IQVIATM sales data for the 12 month period ending August 2019, the Tecfidera Capsules, 120 mg and 240 mg market2 achieved annual sales of approximately $3.7 billion,” Glenmark Pharma said in a filing

New Delhi: Drugmaker, Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed‐Release Capsules, 120 mg and 240 mg, for treating patients with relapsing forms of multiple sclerosis.

The product is a generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc.

According to IQVIATM sales data for the 12 month period ending August 2019, the Tecfidera Capsules, 120 mg and 240 mg market2 achieved annual sales of approximately $3.7 billion.

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Glenmark’s current portfolio consists of 161 products authorized for distribution in the U.S. marketplace and 49 ANDA’s pending approval with the U.S. FDA.

Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. The company has a significant presence in the branded generics markets across emerging economies including India.

Read Also: Glenmark API facility in Baddi gets USFDA warning letter


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