Express Pharma

Lupin receives FDA approval for potassium chloride extended-release capsules

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It is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxications and in patients with hypokalemic familial periodic paralysis

Lupin’s US subsidiary, Gavis Pharmaceuticals (collectively Lupin) has received final approval for its potassium chloride extended-release capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food and Drug Administration (FDA) to market a generic equivalent of Actavis Labs FL, Inc’s potassium chloride extended-release capsules USP, 8 mEq and 10 mEq.

It is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxications and in patients with hypokalemic familial periodic paralysis. It is also indicated for the prevention of hypokalemia in patients who would be at a particular risk if hypokalemia were to develop, e.g., digitalised patients or patients with significant cardiac arrhythmias.

Potassium Chloride extended-release capsules USP, 8 mEq and 10 mEq had US sales of USD 75.4 million (IMS MAT June 2016).

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