FDA Approved: OMEGAVEN — Original Application (Fresenius Kabi USA, LLC)

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Summary

FDA approved OMEGAVEN, a fish oil-based parenteral lipid emulsion, under original NDA 210589 (Fresenius Kabi USA, LLC).

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Diseases / indications

• Cholestasis
• Neonatal Cholestasis
• Parenteral Nutrition Associated Cholestasis

Drugs mentioned

• Omegaven (fish oil-based intravenous fat emulsion)

Snippet

ORIG AP for OMEGAVEN (FISH OIL)