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Glenmark generic of K-Dur approved

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MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has received final Food and Drug Administration approval for potassium chloride extended-release tablets.

Glenmark said Wednesday that its potassium chloride ER tablets, which come in dosages of 10 mEq (750 mg) and 20 mEq (1500 mg), are a generic version of K-Dur ER tablets from Merck Sharp and Dohme Corp. which is no longer being marketed in the United States.

K-Dur is indicated for low levels of potassium in the blood, or hypokalemia. Potassium levels can be low due to disease, certain medications, or severe diarrhea and vomiting.

For the 12 months ended in May, K-Dur ER tablets (10 and 20 mEq) totaled U.S. sales of approximately $283.2 million, according to IMS Health data reported by Glenmark.


ECRM_06-01-22


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