Lupin gets FDA approval for Glumetza ER tablets

Pharma Major Lupin Limited announced today that its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Metformin Hydrochloride extended release tablets (HCl ER) 500 mg and 1000 mg from the United States Food and Drugs Administration (FDA).

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

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Glumetza® HCl ER tablets, 500 mg and 1000 mg had US 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 Release Tablets) 1000 mg and 500 mg from the United States Food and Drugs Administration (FDA) in January, 2012.

Lupin believes that it is the first applicant to file an ANDA for Glumetza® HCL ER Tablets, 500 mg & 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity.