MULTIHANCE (nda021357)- (2.645GM/5ML (529MG/ML),5.29GM/10ML (529MG/ML),7.935GM/15ML (529MG/ML),10.58GM/20ML (529MG/ML))

Generic Name	GADOBENATE DIMEGLUMINE	Innovator	BRACCO
Dosage	2.645GM/5ML (529MG/ML),5.29GM/10ML (529MG/ML),7.935GM/15ML (529MG/ML),10.58GM/20ML (529MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2012-Apr-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MULTIHANCE is indicated for:  magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues.  magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.

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
2.645GM/5ML (529MG/ML)	**	**	-	-	-
5.29GM/10ML (529MG/ML)	**	**	-	-	-
7.935GM/15ML (529MG/ML)	**	**	-	-	-
10.58GM/20ML (529MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of MULTIHANCE