Water Street Company Achieves Another FDA Approval
Water Street announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval of Insulin Human in 0.9% Sodium Chloride Injection (Insulin Human). It is the first and only ready-to-use insulin for IV infusion.
The new presentation of Insulin Human features an extended shelf life of 30 days at room temperature (77 degrees Fahrenheit /25 degrees Celsius) or 24 months if refrigerated (36 – 46 degrees Fahrenheit/2-8 degrees Celsius) in the original carton to protect from light. The product is provided in a standardized concentration of 100 units/100 mL in a flexible plastic container.
The approval of Insulin Human marks the eighth drug product successfully developed by Water Street’s company, Celerity Pharmaceuticals, LLC. Celerity funded, developed, and led the approval process of Insulin Human. After gaining FDA approval, Celerity transferred ownership of the product to its medical products company partner.
“We’re honored to be part of successfully developing this innovative presentation of insulin to advance our partner’s goal of introducing medicines in new presentations that help promote clinician efficiency and advance patient care,” said Dan Robins, Ph.D., president, Celerity.