NOVANTRONE (nda019297)- (EQ 20MG BASE/10ML (EQ 2MG BASE/ML),EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML),EQ 30MG BASE/15ML (EQ 2MG BASE/ML))

Generic Name	MITOXANTRONE HYDROCHLORIDE	Innovator	EMD SERONO
Dosage	EQ 20MG BASE/10ML (EQ 2MG BASE/ML),EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML),EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2006-Apr-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NOVANTRONE is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

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
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	**	**	-	-	-
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	**	**	-	-	-
EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of NOVANTRONE