Granules ANDA for hypertension drug gets USFDA nod

HYDERABAD: Pharma player Granules India Limited on Saturday informed the bourses that the US Food & Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for blood pressure lowering drug Losartan Potassium and Hydrochlorothiazide tablets for 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg strengths.

Granules’ hypertension lowering drug is a generic version of Organon LLC’s reference listed drug (RLD) Hyzaar. Apart from lowering blood pressure the drug also reduces the risk of stoke in patients with hypertension and left ventricular hypertrophy.

The annual market for the drug was pegged at US$73 million as of July 2023, as per estimates.

With this, Granules now has 60 ANDA approvals from the US drug regulator, which includes 58 final approvals and two tentative approvals.