Granules India announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.
It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC.
Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
The current annual U.S. market for Losartan potassium Tablets is approximately $336 Million, according to MAT Dec 2022, IQVIA/IMS Health.
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