MIEBO (NDA216675)- (1.338GM/ML)

Generic Name	PERFLUOROHEXYLOCTANE	Innovator	BAUSCH AND LOMB INC
Dosage	1.338GM/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2037-Jun-21	NCE Excl Expiry	2028-May-18
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.

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
1.338GM/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of MIEBO