FIRVANQ KIT (nda208910)- (EQ 25MG BASE/ML,EQ 50MG BASE/ML)

Generic Name	VANCOMYCIN HYDROCHLORIDE	Innovator	AZURITY
Dosage	EQ 25MG BASE/ML,EQ 50MG BASE/ML
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2035-Mar-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FIRVANQ is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of: • Clostridium difficile-associated diarrhea • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Important Limitations of Use: • Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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 25MG BASE/ML	**	**	Up	1	-
EQ 50MG BASE/ML	**	**	Up	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of FIRVANQ KIT