Pharma major Lupin Ltd. announced that its US subsidiary, Lupin Pharmaceuticals Inc (LPI) has received tentative approval for its metformin hydrochloride extended-release tablets of 500mg and 1000mg strengths from the US Food and Drug Administration.

Lupin’s metformin hydrochloride extended release tablets are the AB rated generic equivalent of Andrx Labs LLC’s Fortamet 500mg and 1000 mg tablets. Fortamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Annual sales for Fortamet in the US was $83 million for the twelve months ending December 2010 as per IMS Health data.

Lupin believes that it is the first applicant to file an ANDA for Fortamet 500mg and 1000 mg containing a paragraph IV certification under the provisions of Hatch-Waxman Act. Upon receiving final approval by the FDA, Lupin believes that the 500 mg and 1000 mg strengths of its product will be entitled to 180 days of marketing exclusivity.

Vinita Gupta, CEO, LPI stated “We are happy to receive this approval. This product approval demonstrates our commitment to enhance our generic pipeline leveraging our development and manufacturing strengths in  extended-release dosage forms.”