MAXITROL (nda050023)- (0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML)

Generic Name	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	Innovator	HARROW EYE
Dosage	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

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
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of MAXITROL