Lupin gets USFDA nod for diabetes drug
New Delhi: Drug major Lupin Monday said it has received US health regulator's approval to sell its generic version of Glumetza HCl ER Tablets, a diabetes drug, in the American market.
The company's US-based subsidiary Lupin Pharmaceuticals Inc has received final approval from US Food and Drug Administration (USFDA) for its Metformin Hydrochloride extended release tablets in strengths of 500 mg and 1000 mg, Lupin Ltd said in a statement.
"Lupin believes that it is the first applicant to file an abbreviated new drug application (ANDA) for Glumetza HCl ER Tablets of 500 mg and 1000 mg strengths, and as such will be entitled to 180 days of marketing exclusivity," it added.
Metformin HCl ER tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
As per IMS Health data, Glumetza HCl ER tablets of 500 mg and 1000 mg had sales of nearly USD 144 million in the US market in 2012-13.
Shares of Lupin today closed at Rs 890.50 apiece on the BSE, down 0.92 percent from their previous close.