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04/06/2021

FDA greenlights Aurobindo’s generic potassium chloride

Aurobindo's generic potassium chloride ER tablets will be offered in dosage strengths of 10 mEq, 15 mEq, and 20 mEq.
Sandra Levy
Senior Editor
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The Food and Drug Administration has given its stamp of approval to Aurobindo for potassium chloride extended-release tablets in dosage strengths of 10 mEq, 15 mEq, and 20 mEq.

The product is the generic of Merck’s potassium chloride ER tablets.

It is used for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis; and 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 ER tablets have a market value of roughly $180 million for the 12 months ending February 2021, according to IQVIA.

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