VIGAMOX (nda021598)- (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	2020-Mar-29	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VIGAMOX is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia trachomatis

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	1	8

Other Developers

Total Other Developers	12

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.5% BASE	**	**	Up	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of VIGAMOX