Express Pharma

Lupin receives FDA approval for generic Klor-Con extended-release tablets

2

It is an electrolyte replenisher for prevention and treatment of hypokalemia

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.

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., digitalised patients or patients with significant cardiac arrhythmia

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

Comments are closed.