Drugs

How to request Omegaven for Expanded Access Use

Contact  

Division of Drug Information (DDI):
toll free at (855) 543-3784 or (301) 796-3400
email: druginfo@fda.hhs.gov

 

Background and Important Safety Information

Omegaven 10% Emulsion is a fish oil emulsion administered intravenously in patients who require parenteral nutrition lipid supplementation and cannot tolerate available lipid emulsions. Omegaven is not approved for marketing in the United States but is approved in Germany. Fresenius Kabi, the manufacturer, has been supplying it for expanded access in the United States. Physicians interested in obtaining expanded access for Omegaven must submit an investigational new drug application (IND). An IND is a request for FDA authorization to administer an investigational new drug (e.g., Omegaven) to humans. Such authorization would allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S.

How to Get Omegaven

Physicians 

You can obtain Omegaven for a single patient by submitting a Single Patient IND (SPI) application to the FDA. FDA generally responds to new Single Patient IND requests within a week or less. Every effort will be made to meet a physician’s request for expedited review. To submit an IND application for Omegaven, please download the Omegaven Single Patient IND Packet, which contains the required forms, instructions and patient questionnaire. It also includes a list of answers to frequently asked questions. In an emergency situation where treatment is necessary before a written submission can be made, an Emergency IND (EIND) can be obtained. Contact DDI (above) for the Omegaven Emergency IND Questionnaire.

Patients 

Please have your physician download the Omegaven Single Patient IND Packet or contact DDI (above) to discuss Omegaven.

Page Last Updated: 04/12/2016
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