Aurobindo gets FDA approval for potassium chloride extended release tablets

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EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application potassium chloride extended-release tablets USP, 10 mEq, 15 mEq, and 20 mEq. Aurobindo Pharma’s potassium chloride extended release tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), potassium chloride extended release tablets of Merck Inc.

Potassium chloride extended-release tablets, is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. It is also indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.

Potassium chloride extended-release tablets has an estimated market size of US $180 million for the twelve months ending February 2021, as per IQVIA.



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