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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: fish oil triglycerides
Trade Name: Omegaven
Date Designated: 02/27/2008
Orphan Designation: Treatment of parenteral nutrition-associated liver disease
Orphan Designation Status: Designated/Approved
Fresenius Kabi USA, LLC
3 Corporate Drive
Lake Zurich, Illinois 60047
United States

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

Marketing approved:

1 Generic Name: fish oil triglycerides
Trade Name: Omegaven
Marketing Approval Date: 07/27/2018
Approved Labeled Indication: Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)
Exclusivity End Date: 07/27/2025 
Exclusivity Protected Indication* :  Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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