Lupin receives US FDA for electrolyte replenisher

Lupin Limited, through its US-based subsidiary Gavis Pharmaceuticals LLC, has received final approval from the US Food and Drug Administration (FDA) to market its potassium chloride extended-release tablet in strengthens of 8 mEq (600 mg) and 10 mEq (750 mg). Potassium chloride extended-release tablet is generic versions of Upsher-Smith Labs’ Klor-Con tablet.

The tablet is an electrolyte replenisher indicated for the therapeutic use of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. It is also prescribed for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, for example, digitalised patients or patients with significant cardiac arrhythmias.

Klor-Con extended-release tablets (8 mEq and 10 mEq) had recorded US sales of $ 101.3 million, according to IMS MAT June 2016.