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PolyHeme Approval Status

  • FDA approved: No
  • Brand name: PolyHeme
  • Generic name: human hemoglobin
  • Company: Northfield Laboratories Inc.
  • Treatment for: Bleeding Disorder

PolyHeme is a human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available.

Development Status and FDA Approval Process for PolyHeme

DateArticle
May  1, 2009Northfield Receives Complete Response Letter for PolyHeme BLA
Dec 30, 2008BLA for PolyHeme Accepted for Filing and Granted Priority Review
Oct 29, 2008Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme

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