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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  triheptanoin
Trade Name:  Dojolvi
Date Designated:  04/15/2015
Orphan Designation:  Treatment of fatty acid oxidation disorders
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/30/2020 
Approved Labeled Indication:  DOJOLVI is indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
Exclusivity End Date:    06/30/2027 
Exclusivity Protected Indication* :  Indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
Ultragenyx Pharmaceutical, Inc.
60 Leveroni Court
Novato, California 94949
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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