AGAMREE (NDA215239)- (40MG/ML)

Generic Name	VAMOROLONE	Innovator	CATALYST PHARMS
Dosage	40MG/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2040-Jul-16	NCE Excl Expiry	2028-Oct-26
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	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
40MG/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of AGAMREE