Nexus obtains FDA OK for sodium chloride injection
Nexus Pharmaceuticals has received the Food and Drug Administration’s green light for 0.9% sodium chloride injection, in 10 ml and 20 ml single-dose vials.
“This product is part of an expanding portfolio of products that address critical healthcare challenges,” said Omair Ahmed, chief operating officer. “Sodium chloride injection is used to treat patients every day in every hospital in the United States. We are grateful to be able to bolster the supply of this critical-need product.”
[Read more: Nexus intros generic Quelicin]
Nexus Pharmaceuticals’ product is expected to launch in October and will be available in cartons of 25 vials.
Sodium chloride injection is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each ml contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
[Read more: Nexus debuts potassium chloride in water for injection]
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.