Glenmark Pharma gets USFDA nod for diabetes management drug
New Delhi: Glenmark Pharmaceuticals on Tuesday said it has received final nod from the US health regulator for metformin hydrochloride tablets used in the management of type-two diabetes.
"Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food & Drug Administration (USFDA) for metformin hydrochloride extended release tablets USP, 500 mg and 1000 mg, the generic version of Glumetza extended release tablets, 500 mg and 1,000 mg, of Salix Pharmaceuticals Inc," the drug maker said in a filing to BSE.
Citing IQVIA sales data for the 12-month period ending September 2019, the company said that Glumetza tablets, 500 mg and 1,000 mg market achieved annual sales of approximately USD 226.7 million.
Glenmark's current portfolio consists of 164 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications pending approval with the USFDA.