Granules India Limited has received the green light from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) covering Losartan Potassium and Hydrochlorothiazide Tablets USP in strengths of 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg.

These approved tablets are deemed bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets, marketed by Organon LLC.

The Losartan potassium and hydrochlorothiazide tablets are prescribed for managing hypertension, effectively lowering blood pressure, and reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy.

This regulatory milestone marks the 60th ANDA approval for Granules from the US FDA, including 58 final approvals and 2 tentative approvals.

As per data from July 2023, the annual US market for Losartan and Hydrochlorothiazide Tablets stands at an estimated USD 73 million, according to IQVIA/IMS Health.