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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution
Trade Name: Extraneal (with 7.5% Icodextrin) Peritoneal Dialysis Solutio
Date Designated: 07/18/1997
Orphan Designation: Treatment of those patients having end stage renal disease and requiring peritoneal dialysis treatment.
Orphan Designation Status: Designated/Approved
Baxter Healthcare Corporation
Renal Division
1620 Waukegan Road
McGaw Park, Illinois 60085
United States

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

Marketing approved:

1 Generic Name: Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution
Trade Name: Extraneal (with 7.5% Icodextrin) Peritoneal Dialysis Solutio
Marketing Approval Date: 12/20/2002
Approved Labeled Indication: For use as a single daily exchange for the long (8-16 hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of chronic renal failure.
Exclusivity End Date: 12/20/2009 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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