The company has also requested priority review, based on the potential for PolyHeme to address a critical, unmet medical need.
By regulation, the FDA has 60 calendar days to review the biologics license application (BLA) for completeness and to make a determination regarding priority review of the application.
Steven Gould, chairman and CEO of Northfield Laboratories, said: “This submission is the culmination of the development of PolyHeme for its initial clinical indication. We firmly believe in PolyHeme’s potential to save the lives of patients for whom blood transfusion is not an option.”