FIRMAGON (nda022201)- (EQ 80MG BASE/VIAL,EQ 120MG BASE/VIAL)

Generic Name	DEGARELIX ACETATE	Innovator	FERRING
Dosage	EQ 80MG BASE/VIAL,EQ 120MG BASE/VIAL
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2032-Apr-27	NCE Excl Expiry	2013-Dec-24
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 80MG BASE/VIAL	**	**	-	-	-
EQ 120MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of FIRMAGON