VUSION (nda021026)- (0.25%;81.35%;15%)

Generic Name	MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE	Innovator	MYLAN
Dosage	0.25%;81.35%;15%
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2028-Mar-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	• VUSION Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. • VUSION Ointment should not be used as a substitute for frequent diaper changes. • VUSION Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.25%;81.35%;15%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VUSION