RADICAVA ORS (nda215446)- (105MG/5ML)

Generic Name	EDARAVONE	Innovator	MITSUBISHI TANABE
Dosage	105MG/5ML
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2039-Nov-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2025-May-12
GAIN Expiry	None	Drug Complexity	No
Indication	RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	10

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
105MG/5ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of RADICAVA ORS