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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: 07/26/1984
Orphan Designation: Treatment of primary and secondary carnitine deficiency of genetic origin.
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: 12/16/1992
Approved Labeled Indication: Treatment of primary systemic carnitine deficiency. (approved 12/27/85) Treatment of secondary carnitine deficiency. (approved 12/16/92)
Exclusivity End Date: 12/16/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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