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Northfield Receives Complete Response Letter for PolyHeme[R] BLA.

Publication: Business Wire
Publication Date: 01-MAY-09
Format: Online
Delivery: Immediate Online Access

Article Excerpt
EVANSTON, Ill. -- Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it has received a complete response letter from the U.S. Food and Drug Administration pertaining to the Company's Biologic License Application for its investigational product, PolyHeme, indicated for the treatment of life-threatening hemoglobin levels when blood transfusion is indicated and red blood cells may not be available.

The letter states that FDA has completed its review of the Company's BLA and finds "that the information and data submitted are inadequate for final approval action."...

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