ZYLET (nda050804)- (0.5%;0.3%)

Generic Name	LOTEPREDNOL ETABONATE; TOBRAMYCIN	Innovator	BAUSCH AND LOMB
Dosage	0.5%;0.3%
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2014-Apr-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZYLET is a combination of loteprednol etabonate, a corticosteroid, and tobramycin, an aminoglycoside antibacterial, indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.5%;0.3%	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ZYLET