KETEK (nda021144)- (300MG,400MG)

Generic Name	TELITHROMYCIN	Innovator	SANOFI AVENTIS US
Dosage	300MG,400MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2018-Apr-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	KETEK is a ketolide antibacterial indicated for the treatment of community-acquired pneumonia of mild to moderate severity.

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
300MG	**	**	-	-	-
400MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of KETEK