ULESFIA (nda022129)- (5%)

Generic Name	BENZYL ALCOHOL	Innovator	SHIONOGI INC
Dosage	5%
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2024-May-19	NCE Excl Expiry	2014-Apr-09
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ULESFIA ® Lotion is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
5%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ULESFIA