Nexus Pharmaceuticals has announced its receipt of approval from the U.S. Food and Drug Administration (FDA) for Potassium Chloride for Injection Concentrate, USP in 10mL and 20mL Single-Dose Vials.

The FDA and the FD&C (Federal Food, Drug, and Cosmetic) Act have determined that the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Injection Concentrate, USP, originally by Hospira, Inc. Additionally, the FDA has granted Competitive Generic Therapy (CGT) designation for the 10mL and 20mL presentations.

Usman Ahmed, President and CEO of Nexus, emphasized that this approval reflects the company's dedication to stabilizing the domestic pharmaceutical supply chain. The product has been included on the FDA's drug shortage list for several years, and Nexus Pharmaceuticals is proud to alleviate this shortage by introducing a domestically manufactured product. This approval marks Nexus' fourth in the current year, with more approvals anticipated as they continue to expand their portfolio of essential medications.

Nexus Pharmaceuticals' Potassium Chloride for Injection Concentrate, USP is set to be launched in the coming weeks and will be available in cartons of 25 vials.

About Potassium Chloride for Injection Concentrate, USP:

Potassium Chloride Injection is a sterile, nonpyrogenic, and highly concentrated solution of Potassium Chloride, USP in Water for Injection, USP. It is designed for electrolyte replenishment and is provided in single-dose containers for intravenous administration.

The primary indication for Potassium Chloride Injection is in the treatment of potassium deficiency states when oral replacement is not feasible.

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