IOMERVU (NDA216016)- (15GM IODINE/50ML (300MG IODINE/ML),25GM IODINE/100ML (250MG IODINE/ML),30GM IODINE/100ML (300MG IODINE/ML),45GM IODINE/150ML (300MG IODINE/ML))

Generic Name	IOMEPROL	Innovator	BRACCO
Dosage	15GM IODINE/50ML (300MG IODINE/ML),25GM IODINE/100ML (250MG IODINE/ML),30GM IODINE/100ML (300MG IODINE/ML),45GM IODINE/150ML (300MG IODINE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	IOMERVU is a radiographic contrast agent indicated for: 1) Intra-arterial Procedures • Cerebral arteriography, including intra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients • Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients • Coronary arteriography and cardiac ventriculography in adults • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients 2)Intravenous Procedures • Computed tomography (CT) of the head and body in adults and pediatric patients • CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients • Coronary CT angiography in adults and pediatric patients • CT urography in adults and pediatric patients

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
15GM IODINE/50ML (300MG IODINE/ML)	**	**	-	-	-
25GM IODINE/100ML (250MG IODINE/ML)	**	**	-	-	-
30GM IODINE/100ML (300MG IODINE/ML)	**	**	-	-	-
45GM IODINE/150ML (300MG IODINE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of IOMERVU