Granules India received an approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets.
It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets of Organon LLC.
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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.
Hyderabad-based Granules now has a total of 60 ANDA approvals from US FDA (58 Final approvals and 2 tentative approvals).
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The current annual U.S. market for Losartan and Hydrochlorothiazide Tablets is approximately $73 Million, according to a release.