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Lupin’s potassium deficiency drug gets FDA approval

lupinLupin Ltd announced today that its US subsidiary, Gavis Pharmaceuticals LLC, has received final approval for its Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food and Drug Administration (FDA).

The capsule is for the treatment of patients with hypokalemia, or the deficiency of potassium in the bloodstream.

It can also be used in patients with hypokalemic familial periodic paralysis and in patients who would be at a particular risk if hypokalemia were to develop with significant cardiac problems.

Lupin’s Potassium Chloride Extended-Release Capsules USP are the AB rated generic equivalent of Actavis Labs’s Potassium Chloride Extended-Release Capsules USP.

Potassium Chloride Extended-Release Capsules USP, 8 mEq and 10 mEq had US sales of $75.4 million (IMS MAT June 2016).

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

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