Granules India receives USFDA approval for Potassium Chloride Extended-Release Tablets

Granules India has received US Food & Drug Administration approval for the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India for Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) . It is bioequivalent to the reference listed drug product (RLD), Klor-Con Extended- Release Tablets, 8 mEq (600 mg) and 10 mEq (750 mg), of Upsher-Smith Laboratories, LLC.( Klor-Con is a trademark of Upsher-Smith Laboratories, LLC.)

Potassium Chloride ER Tablets are used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

 

The Klor-Con brand and generic had U.S. sales of approximately $54 million MAT for the most recent twelve months ending in December 2019 according to IQVIA Health.

Granules now have a total of 24 ANDA approvals from US FDA (22 Final approvals and 2 tentative approvals).

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