Pharma major Lupin’s US arm Gavis Pharmaceuticals LLC has received final approval from the USFDA for its generic version of Upsher-Smith Labs’ Klor-Con tablets used for treating potassium deficiency in blood.
The approval by the US health regulator for potassium chloride extended-release tablets USP are for multiple strengths of 8 mEq (600 mg) and 10 mEq (750 mg), Lupin said in a statement.
The tablets, which is an electrolyte, is used in treatment of patients with hypokalemia (potassium deficiency), with or without metabolic alkalosis; in digitalis intoxication and in patients with hypokalemic familial periodic paralysis.
It is also used for prevention of hypokalemia in patients who would be at particular risk if the condition were to develop.
Citing IMS MAT June 2016 data, Lupin said Klor-Con tablets had sales of USD 101.3 million in the US.