MOXEZA (nda022428)- (EQ 0.5% BASE)

Generic Name	MOXIFLOXACIN HYDROCHLORIDE	Innovator	HARROW EYE
Dosage	EQ 0.5% BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-May-29	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2013-Nov-19
GAIN Expiry	None	Drug Complexity	No
Indication	MOXEZA is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections.

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
EQ 0.5% BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of MOXEZA