Lupin gets USFDA approval for generic Potassium Chloride Oral Solution

The company's product is a generic version of Genus Lifesciences Inc's Potassium chloride oral solution in the same strengths

New Delhi: Drug firm Lupin said it has received approval from the US health regulator to sell its potassium chloride oral solution used for the treatment of low potassium levels in the American market.

The company has received approval to market its Potassium chloride oral solution USP, in the strengths of 20 mEq/15 mL (10 percent) and 40 mEq/15 mL (20 percent) from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.

The company's product is a generic version of Genus Lifesciences Inc's Potassium chloride oral solution in the same strengths, it added.

As per IQVIA MAT June 2018 data, the oral solution in the two strengths had annual sales of around USD 184.95 million in the US, Lupin said.

"The product is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods and/or diuretic dose reduction are insufficient," it added.