GADAVIST (nda201277)- (1.20944GM/2ML (604.72MG/ML),4.5354GM/7.5ML (604.72MG/ML),6.0472GM/10ML (604.72MG/ML),9.0708GM/15ML (604.72MG/ML),18.1416GM/30ML (604.72MG/ML),39.3068GM/65ML (604.72MG/ML))

Generic Name	GADOBUTROL	Innovator	BAYER HLTHCARE
Dosage	1.20944GM/2ML (604.72MG/ML),4.5354GM/7.5ML (604.72MG/ML),6.0472GM/10ML (604.72MG/ML),9.0708GM/15ML (604.72MG/ML),18.1416GM/30ML (604.72MG/ML),39.3068GM/65ML (604.72MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2016-Nov-09	NCE Excl Expiry	2016-Mar-14
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Gadavist is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients (including term neonates) • To assess the presence and extent of malignant breast disease in adult patients • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	2

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1.20944GM/2ML (604.72MG/ML)	**	**	-	-	-
4.5354GM/7.5ML (604.72MG/ML)	**	**	-	-	-
6.0472GM/10ML (604.72MG/ML)	**	**	-	-	-
9.0708GM/15ML (604.72MG/ML)	**	**	-	-	-
18.1416GM/30ML (604.72MG/ML)	**	**	-	-	-
39.3068GM/65ML (604.72MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of GADAVIST