Glenmark Pharmaceuticals receives tentative approval for Dimethyl Fumarate capsules

Glenmark Pharmaceuticals 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, a generic version of Tecfidera1 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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