Aurobindo Pharma gets USFDA nod for Potassium Chloride extended-release tablets
New Delhi: Aurobindo Pharma on Friday said it has received final approval from the US health regulator to manufacture and market Potassium Chloride extended-release tablets, used in the treatment of hypokalemia. "The company has received final approval from the US Food and Drug Administration (USFDA) for Potassium Chloride extended-release tablets in the strengths of 8 mEq (600 mg) and 10 mEq (750 mg)," Aurobindo Pharma said in a BSE filing.
The approved product is a generic version of Upsher-Smith's Klor-Con extended-release tablets.
Hypokalemia is a condition wherein blood's potassium levels are too low.
Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 60 million for the twelve months ended October 2018.
This is the 5th ANDA (abbreviated new drug application), including 2 tentative approvals, to be approved out of Unit X formulation facility in Naidupet, Andhra Pradesh used for manufacturing oral products, the company said.
Aurobindo Pharma now has a total of 396 ANDA approvals (368 final approvals including 20 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.