Application Nr Approved Date Route Status External Links
NDA210589 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Omegaven Is Indicated As A Source Of Calories And Fatty Acids In Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (Pnac). Limitations Of Use: Omegaven Is Not Indicated For The Prevention Of Pnac. It Has Not Been Demonstrated That Omegaven Prevents Pnac In Parenteral Nutrition (Pn)-Dependent Patients [See Clinical Studies ( 14 )]. It Has Not Been Demonstrated That The Clinical Outcomes Observed In Patients Treated With Omegaven Are A Result Of The Omega-6:omega-3 Fatty Acid Ratio Of The Product [See Clinical Studies ( 14 )]. Omegaven Is Indicated As A Source Of Calories And Fatty Acids In Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (Pnac). ( 1 ) Limitations Of Use: Omegaven Is Not Indicated For The Prevention Of Pnac. It Has Not Been Demonstrated That Omegaven Prevents Pnac In Parenteral Nutrition (Pn)-Dependent Patients. ( 1 ) It Has Not Been Demonstrated That The Clinical Outcomes Observed In Patients Treated With Omegaven Are A Result Of The Omega-6:omega-3 Fatty Acid Ratio Of The Product. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fish Oil

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