CAYSTON (nda050814)- (75MG/VIAL)

Generic Name	AZTREONAM	Innovator	GILEAD
Dosage	75MG/VIAL
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2021-Dec-20	NCE Excl Expiry	Expired
ODE Expiry	2017-Feb-22	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CAYSTON is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis(CF) patients with Pseudomonas aeruginosa.

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
75MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CAYSTON