DUVYZAT (NDA217865)- (EQ 8.86MG BASE/ML)

Generic Name	GIVINOSTAT HYDROCHLORIDE	Innovator	ITALFARMACO SPA
Dosage	EQ 8.86MG BASE/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2036-Oct-28	NCE Excl Expiry	2029-Mar-21
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 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
EQ 8.86MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of DUVYZAT