Glenmark gets tentative FDA nod for Sanofi's generic Multaq
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New Delhi: Glenmark Pharmaceuticals today said it has received a tentative nod from the US health regulator for generic version of Sanofi-Aventis' cardiac drug Multaq.
In a BSE filing, Glenmark said it "has been granted tentative approval by the US Food & Drug Administration (USFDA) for its Dronedarone Tablets, 400 mg, the generic version of Multaq Tablet, 400 mg of Sanofi-Aventis U.S. LLC."
However, the company cannot sell the product in the US as it is involved in a patent litigation with Sanofi in the district court of Delaware.
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