CRESEMBA (nda207500)- (74.5MG,186MG)

Generic Name	ISAVUCONAZONIUM SULFATE	Innovator	ASTELLAS
Dosage	74.5MG,186MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Mar-14	NCE Excl Expiry	2020-Mar-06
ODE Expiry	2022-Mar-06	NP Expiry	None
GAIN Expiry	2025-Mar-06	Drug Complexity	No
Indication	CRESEMBA ® is an azole antifungal indicated for use in the treatment of: • Invasive aspergillosis. • Invasive mucormycosis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	12

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
74.5MG	**	**	-	-	-
186MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CRESEMBA