ARTESUNATE (nda213036)- (110MG/VIAL)

Generic Name	ARTESUNATE	Innovator	AMIVAS
Dosage	110MG/VIAL
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2044-Feb-16	NCE Excl Expiry	2025-May-26
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
110MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ARTESUNATE