QUIXIN (nda021199)- (0.5%)

Generic Name	LEVOFLOXACIN	Innovator	SANTEN
Dosage	0.5%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2010-Dec-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	QUIXIN ® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: *Gram-positive bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumonia, Streptococcus (Groups C/F), Streptococcus (Group G), Viridans group streptococci. *Gram-negative bacteria: Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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
0.5%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of QUIXIN