OMEGAVEN (nda210589)- (5GM/50ML (0.1GM/ML),10GM/100ML (0.1GM/ML))

Generic Name	FISH OIL TRIGLYCERIDES	Innovator	FRESENIUS KABI USA
Dosage	5GM/50ML (0.1GM/ML),10GM/100ML (0.1GM/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2025-Jul-11	NCE Excl Expiry	2023-Jul-27
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5GM/50ML (0.1GM/ML)	**	**	-	-	-
10GM/100ML (0.1GM/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OMEGAVEN