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Northfield PolyHeme priority review status brings April user fee goal

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Northfield Laboratories' PolyHeme application carries a user fee goal date of April 30 following FDA's designation of the BLA for priority review status. PolyHeme could be the first blood substitute on the market. The human hemoglobin-based red blood cell substitute seeks an indication for treatment of life-threatening RBC loss when an oxygen-carrying fluid is required and red blood cells are not available. The BLA is supported by a Phase III randomized, double-blind trial in 720 trauma patients (1"The Pink Sheet" DAILY, Aug. 15, 2007)

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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