Drug firm Granules India Monday said its arm has received approval from the US health regulator for Potassium Chloride Oral Solution USP, used for prevention and treatment of low blood levels of potassium.
The approved product is bioequivalent to the reference listed drug Potassium Chloride Oral Solution of Genus Lifesciences, Inc.
In a BSE filing, Granules said the US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of Granules India Ltd, for Potassium Chloride Oral Solution USP.
Granules Pharmaceuticals Executive Director Priyanka Chigurupati said: "We are pleased to announce approval of the first oral liquid product from our growing product portfolio in the US market. This is the third approval in the Potassium Chloride product basket reiterating our focussed portfolio strategy”.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Granules now has a total of 36 ANDA approvals from USFDA (35 final approvals and 1 tentative approvals).
Quoting IQVIA Health data, Granules said Potassium Chloride Oral solution products had US sales of approximately $75 million for the most recent 12 months ending in November 2020.
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