USFDA gives nod for Granules copy of blood pressure tablet
The Hindu
Losartan potassium tablets are indicated for the treatment of hypertension in adults and paediatric patients — six years of age and older — to lower blood pressure
Drugmaker Granules India has received the U.S. Food and Drug Administration (USFDA) approval for a generic version of Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg that are indicated for treatment of hypertension.
The approved product is bioequivalent to reference listed drug product Cozaar Tablets of Organon LLC.
The current annual U.S. market for Losartan potassium tablets is around $336 million, according to MAT Dec 2022, Granules said citing IQVIA/IMS Health numbers.
Losartan potassium tablets are indicated for the treatment of hypertension in adults and paediatric patients — six years of age and older — to lower blood pressure. Granules said with this it has 54 ANDA (abbreviated new drug application) approvals from the U.S. FDA, including two tentative approvals.
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