Industry

USFDA gives nod to Granules Pharma for potassium chloride for oral solution

The product would be available for the US market shortly.

January 31, 2022

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USFDA Drug product Approval — USFDA Approval

Last Updated on December 31, 2023 by The Health Master

The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI)., a wholly-owned foreign subsidiary of Granules India Ltd, for potassium chloride for oral solution USP, 20 mEq.

Potassium chloride is used to prevent or treat low blood potassium levels (hypokalemia). It is bioequivalent to the referenced drug product, Potassium Chloride for Oral Solution, 20 mEq, of Pharma Research Software Solution, LLC.

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The product would be available for the US market shortly.

“We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market,” Priyanka Chigurupati, Executive Director, GPI, said in a press statement.

Granules now has a total of 49 ANDA approvals from the USFDA (47 final approvals and two tentative approvals).

The current annual US market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $44 million, according to MAT Nov 2021, IQVIA/IMS Health.

Other approvals by USFDA

USFDA gives nod to Glenmark this for Blood Pressure drug

USFDA gives Orphan Drug Designation to Eplontersen

USFDA’s response on Chronic Cough treatment

USFDA gives nod to FDC for Ofloxacin Otic Solution

USFDA gives conditional nod to Glenmark for generic Regadenoson injection

USFDA gives final approval to Zydus for Vigabatrin tablets

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