FDA approves Lupin’s generic Klor-Con

MUMBAI — The Food and Drug Administration has approved Lupin subsidiary Gavis Pharmaceuticals’ generic of Klor-Con  (potassium chloride) extended-release tablets, the company announced Wednesday. The drug is indicated to treat patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and patients with hypokalemic familial periodic paralysis. It’s also indicated to prevent hypokalemia in patients at risk if they developed it — for example, patients with significant cardiac arrhythmias. 

 

Lupin’s generic will be available in 600- and 800-mg dosage strengths. U.S. sales for the product were $101.3 million for the 12 months ended June 2016, according to IMS Health.