Lupin receives FDA approval for generic Klor-Con Extended-Release Tablets

11 Aug 2016 Evaluate

Lupin’s US subsidiary, Gavis Pharmaceuticals LLC., USA (collectively Lupin) has received final approval for its Potassium Chloride Extended-Release Tablets 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 Upsher-Smith Labs Klor-Con Extended-Release Tablets, 8 mEq and 10 mEq. Klor-Con Extended-Release Tablets, 8 mEq and 10 mEq had US sales of $101.3 million, as per IMS MAT June 2016.

Lupin’s Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) are the AB rated generic equivalent of Upsher-Smith Labs Klor-Con Extended-Release Tablets, 8 mEq and 10 mEq. It 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. The prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally.


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