Glenmark Pharma receives USFDA final approval for Fumarate Delayed-Release Capsules

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (USFDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, the generic version of Tecfidera1 Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc.

According to IQVIATM sales data for the 12 month period ending August, the Tecfidera Delayed-Release Capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.8 billion.

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