FDA approval for Generic Glumetza: Lupin

Glumetza HCl ER tablets, 500 mg and 1000 mg had U.S sales of approximately US$ 144 million, for the twelve months ending March, 2013 (IMS Health data). Lupin had earlier received the tentative approval for generic GLUMETZA(Metformin Hydrochloride Extended


Lupin limited pharma major announced today that its U.S. subsidiary, Lupin Pharmaceuticals, Inc (LPI) has bagged final approval for its Metformin Hydrochloride extended release tablets (HC1 Er) 500 mg and 1000 mg from the United States Food and Drug Administration (USFDA).

Lupin's Metformin HC1 ER Tablets, 500 mg and 1000 mg strengths are the AB-rated generic equivalent of Santarus, Inc.'s Glumetza HC1 ER Tablets, 500 mg and 100 mg. Metformin HC1 Er tablets is a biguanide and is indicated as an adjunct to diet and excercise to improve glycemic control in adults with type 2 diabetes mellitus.

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CASI 13 January 2014 at 11:20 AM

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