MYCAMINE (nda021506)- (EQ 50MG BASE/VIAL,EQ 100MG BASE/VIAL)

Generic Name	MICAFUNGIN SODIUM	Innovator	ASTELLAS
Dosage	EQ 50MG BASE/VIAL,EQ 100MG BASE/VIAL
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Jul-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MYCAMINE® is an echinocandin indicated in adult and pediatric patients for:  Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.  Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.  Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.  Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	8

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 50MG BASE/VIAL	**	**	-	-	-
EQ 100MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of MYCAMINE