Strides gets USFDA nod for hypokalemia treatment drug

NEW DELHI, Sept 5: Strides Pharma Science Wednesday said its step-down wholly owned subsidiary has received approval from the US health regulator for Potassium Chloride extended-release tablets, used to treat hypokalemia.
Hypokalemia occurs when blood’s potassium levels are too low.
“Strides Pharma Global Pte. Ltd, Singapore, has received approval for Potassium Chloride extended release tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food and Drug Administration (USFDA),” Strides Pharma Science said in a regulatory filing.
Potassium Chloride extended-release tablet is a generic version of Klor-Con extended-release tablet of Upsher-Smith and Strides is the first Indian generic company to receive this approval.
Quoting IQVIA MAT data, Strides Pharma Science said the US market for Potassium Chloride extended release tablets is approximately USD 60 million.
The company said it has 78 cumulative ANDA filings with USFDA of which 52 ANDAs have been approved as of date and 26 are pending approval. (PTI)