Pharmacy

Pharma major, Lupin Ltd has said that its US subsidiary, Lupin Pharmaceutical, Inc (LPI) has received tentative approval for its  metformin hydrochloride extended-release tablets, 500 mg and 1000  strengths from the US Food and Drug Administration (FDA).  Lupin's melfonnin Hydrochloride extended-release tablets are the AB-rated generic equivalent of Andrx Labs LLC's TortameS® 500 mgand 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 Fortamel® in the US was $83 million for the 12 months ending December 2010, as per IMS Health data.

Luph"! believes that it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Fortamet® 500 mg and 1000 mg containing a Paragraph FV certification, under the provisions of the Hatch-Waxman Act The product will be entitled to 180 days of marketing exclusivity Speaking on the approval, Vinita Gupta, CEO, Lupin Pharmaceuticals, Inc. stated, "This product approval demonstrates our commitment to enhance our generic pipeline, leveraging our development and manufacturing strengths in extended- release dosage forms."