FDA approval for Generic Glumetza: Lupin
25 July 2013 | News | By BioSpectrum Bureau
FDA approval for Generic Glumetza: Lupin
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.
