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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Levocarnitine
Trade Name: Carnitor
Date Designated: 09/06/1988
Orphan Designation: Treatment of manifestations of carnitine deficiency in patients with end stage renal disease who require dialysis.
Orphan Designation Status: Designated/Approved
Leadiant Biosciences, Inc.
9841 Washingtonian Blvd
Suite 500
Gaithersburg, Maryland 20878
United States

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

Marketing approved:

1 Generic Name: Levocarnitine
Trade Name: Carnitor
Marketing Approval Date: 12/15/1999
Approved Labeled Indication: Prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
Exclusivity End Date: 12/15/2006 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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