NEW DELHI: Drug firm Strides Pharma Science on Monday said its step-down subsidiary, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for potassium chloride for oral solution, used for prevention and treatment of low blood levels of potassium.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Oral Solution USP, 20 mEq, of Pharma Research Software Solution, LLC.
Strides Pharma Global, Singapore, has received approval for Potassium Chloride for Oral Solution USP, 20 mEq from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Quoting IQVIA moving annual total (MAT) January 2021 data, Strides Pharma Science said the US market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately USD 56 million.
The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the US market.
The company has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA, of which 100 ANDAs have been approved and 27 are pending for approval.
Potassium Chloride Oral Solution 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.
Shares of Strides Pharma Science were trading 0.07 per cent lower at Rs 837 apiece on BSE.
Source: Press Trust of India