The Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg has been approved by the US Food & Drug Administration (US FDA), according to a statement released by Granules India today.

It is bioequivalent to Organon LLC′s Cozaar Tablets, a reference listed drug product (RLD).

The US FDA has currently approved 54 ANDAs for granules (52 Final approvals and 2 tentative approvals).

For the treatment of hypertension in adults and paediatric patients 6 years of age and older, losartan potassium tablets are recommended since they reduce blood pressure.

According to MAT Dec 2022, IQVIA/IMS Health, the current annual U. S. market for losartan potassium tablets is around $336 million.

(Source:  https://www.business-standard.com/article/news-cm/granules-india-receives-usfda-approval-for-losartan-potassium-tablets-123022700209_1.html)