Glenmark Pharma gets USFDA nod for hypertension drug

 

NEW DELHI, Mar 5: Glenmark Pharmaceuticals Tuesday said it has received final approval from the US health regulator for Telmisartan and Hydrochlorothiazide tablets, used to treat high blood pressure (hypertension).

The approved products is a generic version of Boehringer Ingelheim Pharmaceuticals Inc’s Micardis HCT tablets.

Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Telmisartan and Hydrochlorothiazide Tablets USP in the strengths of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg, the company said in a BSE filing.

Quoting IQVIA sales data for the 12 month period ending January 2019, Glenmark said the Micardis HCT tablets market achieved annual sales of approximately USD 40.6 million.

The company’s current portfolio consists of 150 products authorised for distribution at the US marketplace and 52 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.

(PTI)