Main > A2. TRADEMARK. INDEX. Pn-Pz > PolyHeme

Product USA. N

GENERIC NAME This data is not available for free
INDICATION'S Trauma
OBSERVATION'S Pyridoxylated & XL with GlutarAldehyde
STATUS determined to wind down its business operations and carry out an orderly disposition of its assets.

Following its review and analysis of the complete response letter received from the Food and Drug Administration on April 30, 2009, Northfield determined that further clinical development of a reformulated version of its PolyHemeŽ human red cell substitute product, including additional clinical trials, would likely be required before it could again seek to obtain FDA approval. Northfield concluded that the time and substantial expense required to complete this additional clinical development, together with significant uncertainty that FDA approval would ultimately be obtained, made it unlikely that sufficient additional capital could be raised to support such further product development.

On May 8, 2009, Northfield announced that it had terminated substantially all operational and staff employees at its manufacturing facility and headquarters.

UPDATE 05.2009
COMPANY This data is not available for free
PATENT NUMBER This data is not available for free

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