Granules India gets USFDA nod for hypertension drug

BL Hyderabad Bureau Updated - February 27, 2023 at 04:13 PM.

The drug is indicated for treatment of hypertension in adults and paediatric patients 6 years of age and older

Hyderabad, Feb 27 Granules India has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Losartan Potassium tablets.

It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Losartan potassium tablets are indicated for the treatment of hypertension in adults and paediatric patients 6 years of age and older, to lower blood pressure. 

The current annual US market for Losartan potassium tablets is approximately $336 million, according to a release. Granules now has a total of 54 ANDA approvals from USFDA (52 final approvals and two tentative approvals).

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Published on February 27, 2023 10:43
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