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Granules gets USFDA nod for hypertension drug

Granules gets USFDA nod for hypertension drug

Hyderabad-headquartered pharmaceutical major Granules India Limited announced that the US Food and 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.

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

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