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Glenmark Pharmaceuticals receives tentative approval for Dabigatran Etexilate Capsules

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Last Updated : Apr 19 2017 | 9:47 AM IST

From USFDA

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg, the generic version of Pradaxa Capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IMS Health sales data for the 12 month period ending February 2017, the Pradaxa Capsules, 75 mg, 110 mg and 150 mg market1 achieved annual sales of approximately $913 million.

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First Published: Apr 19 2017 | 9:26 AM IST

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