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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: phoxillum
Trade Name:
Date Designated: 02/14/2014
Orphan Designation: For use as a replacement solution in patients undergoing continuous renal replacement therapy
Orphan Designation Status: Designated/Approved
Gambro Renal Products, Inc.
1845 Mason Avenue
Daytona Beach, Florida 32117
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: phoxillum
Trade Name:
Marketing Approval Date: 01/13/2015
Approved Labeled Indication: As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialzable substances
Exclusivity End Date: 01/13/2022 
Exclusivity Protected Indication* :  As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialzable substances
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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