Drug firm Lupin said it has received approval from the US health regulator for its Metformin Hydrochloride Extended Release tablets, used in treating diabetes.
The company's US-based subsidiary Lupin Pharmaceuticals Inc has received tentative approval from US Food and Drug Administration ( USFDA) for Metformin tablets in strengths of 500 mg and 1,000 mg, Lupin said in a statement.
Lupin's Metformin HCl ER Tablets are the AB-rated generic equivalent of Santarus Inc's Glumetza HCl ER Tablets, it added.
'Lupin believes that it is the first applicant to file an abbreviated new drug application ( ANDA) for Glumetza HCL ER Tablets, 500 mg and 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity,' the company said.
According to IMS Health data, Glumetza HCl ER tablets in strengths of 500 mg and 1,000 mg had annual US sales of nearly $58 million for the 12 months to September, 2011.
Metformin HCl ER tablets is a biguanide and is indicated as an supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
....more info
The company's US-based subsidiary Lupin Pharmaceuticals Inc has received tentative approval from US Food and Drug Administration ( USFDA) for Metformin tablets in strengths of 500 mg and 1,000 mg, Lupin said in a statement.
Lupin's Metformin HCl ER Tablets are the AB-rated generic equivalent of Santarus Inc's Glumetza HCl ER Tablets, it added.
'Lupin believes that it is the first applicant to file an abbreviated new drug application ( ANDA) for Glumetza HCL ER Tablets, 500 mg and 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity,' the company said.
According to IMS Health data, Glumetza HCl ER tablets in strengths of 500 mg and 1,000 mg had annual US sales of nearly $58 million for the 12 months to September, 2011.
Metformin HCl ER tablets is a biguanide and is indicated as an supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
....more info