TIGLUTIK KIT (nda209080)- (50MG/10ML)

Generic Name	RILUZOLE	Innovator	ITALFARMACO SA
Dosage	50MG/10ML
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2029-Mar-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	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
50MG/10ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TIGLUTIK KIT