Nexus Pharmaceuticals announced it received FDA approval for Potassium Chloride for Injection Concentrate, USP in 10mL and 20mL Single-Dose Vials. According to the FDA and the FD&C (Federal Food, Drug, and Cosmetic) Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Injection Concentrate, USP, of Hospira, Inc. Furthermore, the FDA has granted CGT (competitive generic therapy) designation for the 10mL and 20mL presentations.
“This approval highlights Nexus’ commitment to stabilizing the domestic pharmaceutical supply chain,” said Usman Ahmed, President and CEO of Nexus. “Potassium Chloride for Injection Concentrate has been on the FDA’s drug shortage list for several years and we are very proud to alleviate this shortage with a product manufactured in the United States. This product represents our fourth approval this year with many more to come as we continue to expand our portfolio of critical need medications.”
Nexus Pharmaceuticals’ Potassium Chloride for Injection Concentrate, USP is expected to launch in the next few weeks and will be available in cartons of 25 vials.
About Potassium Chloride for Injection Concentrate, USP
Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration.
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
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