Strides Pharma gets FDA approval for Potassium Chloride Oral Solution generic
Strides Pharma Science has secured approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the US Food & Drug Administration (FDA).
The approval was bagged by the Indian pharma company’s step-down fully-owned subsidiary — Strides Pharma Global Pte. Limited, Singapore.
The approved product is the generic of Genus Lifesciences’ Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%).
Potassium Chloride Oral Solution has FDA approval for treating and preventing hypokalemia with or without metabolic alkalosis in patients whose dietary management with potassium rich foods or reduction of diuretic dose are not enough.
According to Strides Pharma Science, the approval further bolsters its Potassium Chloride franchise, which is now made up of Extended-Release Capsules, Extended-Release Tablets, Powder for Oral Solutions, and Oral Solutions.
Strides Pharma Science also has a pipeline of other Potassium Chloride products which are likely to be approved and rolled out in the financial year of 2024.
The Indian pharma company said that the products will be manufactured at its Bengaluru facility and will be commercialized by Strides Pharma in the American market.