VELETRI (nda022260)- (EQ 1.5MG BASE/VIAL,EQ 0.5MG BASE/VIAL)

Generic Name	EPOPROSTENOL SODIUM	Innovator	ACTELION
Dosage	EQ 1.5MG BASE/VIAL,EQ 0.5MG BASE/VIAL
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2027-Mar-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VELETRI is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1.5MG BASE/VIAL	**	**	-	-	-
EQ 0.5MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of VELETRI