Lupin receives USFDA approval for Potassium Chloride Extended Release Capsules

24 Dec 2015 Evaluate

Lupin has received final approval for its Potassium Chloride Extended Release Capsules USP, 8 mEq and 10 mEq from the United States Food and Drug Administration (USFDA) to market a generic version of Actavis Labs FL, Inc’s Potassium Chloride Extended Release Capsules USP, 8 mEq and 10 mEq. Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. shall commence promoting the product in the US shortly. Potassium Chloride Extended Release Capsules had US sales of $85.6 million, as per IMS MAT September 2015.

Lupin’s Potassium Chloride Extended Release Capsules USP, 8 mEq and 10 mEq, are the AB rated 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.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.


 

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