Omegaven 10% Emulsion is a fish oil emulsion administered intravenously in patients who require parenteral nutrition supplementation with long chain omega-3 fatty acids, especially eicosapentaenoic and docosahexaenoic acid, when oral or enteral nutrition is impossible, insufficient or contraindicated. 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 investigation 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.
Single Patient IND (SPIs)
Physicians 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. Contact the DDI (below) to request the Omegaven Single Patient IND Packet.
Emergency IND (EINDs)
Physicians may seek emergency access to Omegaven for an individual patient (see 21 CFR 312.310(d). An emergency IND (EIND) is applicable when the patient requires treatment before a written submission can be made. Contact DDI (below) to request the Omegaven Emergency IND Questionnaire.
Division of Drug Information (DDI):
toll free (855)-543-3784 or (301) 796-3400