Last Updated on December 31, 2023 by The Health Master
USFDA Approved Potassium Chloride
In a significant development, Nexus Pharmaceuticals has officially secured approval from the U.S. Food and Drug Administration (USFDA) for its Potassium Chloride for Injection Concentrate, USP, available in 10 mL and 20 mL single-Dose Vials.
This regulatory milestone is a testament to Nexus’ steadfast commitment to ensuring the stability of the domestic pharmaceutical supply chain.
FDA Recognition of Bioequivalence and Therapeutic Equivalence
According to the USFDA and the FD&C (Federal Food, Drug, and Cosmetic) Act, the recently approved product has been designated as bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Injection Concentrate, USP, originally developed by Hospira, Inc.
Additionally, a competitive generic therapy (CGT) designation has been granted by the USFDA for both the 10 mL and 20 mL presentations, underscoring the innovative approach that Nexus Pharmaceuticals has taken.
Eradicating Drug Shortages: A Significant Milestone
Commenting on this crucial approval, Usman Ahmed, the President and CEO of Nexus, expressed his views:
“This approval highlights Nexus’ commitment to stabilizing the domestic pharmaceutical supply chain.”
“Potassium Chloride for Injection Concentrate has been on the USFDA’s drug shortage list for several years, and we are very proud to alleviate this shortage with a product manufactured in the United States.”
Ahmed went on to highlight that this marks the fourth approval achieved by Nexus this year alone, with many more anticipated as the company expands its portfolio to encompass critical need medications.
Product Launch and Availability
Nexus Pharmaceuticals’ Potassium Chloride for Injection Concentrate, USP is poised for an imminent launch, expected to take place within the upcoming weeks.
The product will be offered in cartons containing 25 vials, ensuring accessibility and convenience for medical practitioners and patients alike.
About Potassium Chloride for Injection Concentrate, USP
Potassium Chloride for Injection Concentrate, USP stands as a sterile, nonpyrogenic solution that is highly concentrated and ready for immediate use.
The solution contains Potassium Chloride, USP, dissolved in Water for Injection, USP, making it an optimal choice for replenishing electrolytes in cases where oral replacement is not a viable option.
The administration is performed intravenously, and this therapy is indicated for patients facing potassium deficiency states.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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