ZYFLO (nda020471)- (300MG,600MG)

Generic Name	ZILEUTON	Innovator	CHIESI
Dosage	300MG,600MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2010-Dec-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	9

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
300MG	**	**	-	-	-
600MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ZYFLO