NUVESSA (nda205223)- (1.3%)

Generic Name	METRONIDAZOLE	Innovator	CHEMO RESEARCH SL
Dosage	1.3%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2032-Jun-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2017-Mar-24
GAIN Expiry	None	Drug Complexity	No
Indication	NUVESSA is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1.3%	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of NUVESSA