Granules India gets USFDA nod for Losartan Potassium & Hydrochlorothiazide Tablets

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg. 

It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets of Organon LLC, the company said.

Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. 

Now, as per the regulatory filing, Granules have a total of 60 ANDA approvals from US FDA (58 Final approvals and 2 tentative approvals). 

The current annual U.S. market for Losartan and Hydrochlorothiazide Tablets is approximately $73 Million, according to MAT Jul 2023, IQVIA/IMS Health.