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