New Delhi: Drug maker Lupin on Wednesday said it has received tentative approval from US health regulator for its generic Metformin Hydrochloride extended-release tablets, used in the treatment of diabetes, in the American market.
The company’s US arm Lupin Pharmaceuticals Inc has received approval from the US Food and Drug Administration (USFDA) for Metformin Hydrochloride extended-release tablets in the strengths of 500 mg and 1000 mg, Lupin said in a statement.
The company’s product is generic equivalent of Andrx Labs LLC’s Fortamet 500 mg and 1000 mg tablets and is indicated as a supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it said.
Commenting on the approval, Lupin Pharmaceuticals CEO Vinita Gupta said: “This product approval demonstrates our commitment to enhance our generic pipeline, leveraging our development and manufacturing strengths in extended-release dosage forms.”
The company believes it is the first applicant to file an abbreviated new drug application for Fortamet 500 mg and 1,000 mg and that could translate into 180 days of marketing exclusivity for its product.
“Upon receiving final approval by the FDA, Lupin believes that the 500 mg and 1,000 mg strengths of its product will be entitled to 180 days of marketing exclusivity,” it said.
As per IMS Health data, annual sales for Fortamet in the US stood at $83 million for the 12 months ending December, 2010, it added.
Shares of Lupin were on Wednesday trading at Rs411.90 on the Bombay Stock Exchange (BSE) in the late afternoon trade, up 0.99% from its previous close.