BREXAFEMME (nda214900)- (EQ 150MG BASE)

Generic Name	IBREXAFUNGERP CITRATE	Innovator	SCYNEXIS
Dosage	EQ 150MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2039-Jun-10	NCE Excl Expiry	2026-Jun-01
ODE Expiry	None	NP Expiry	None
GAIN Expiry	2031-Jun-01	Drug Complexity	No
Indication	BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).

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 150MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of BREXAFEMME