ZERBAXA (nda206829)- (EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL)

Generic Name	CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM	Innovator	CUBIST PHARMS LLC
Dosage	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2035-Aug-14	NCE Excl Expiry	2019-Dec-19
ODE Expiry	None	NP Expiry	None
GAIN Expiry	2024-Dec-19	Drug Complexity	No
Indication	ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole, in adult and pediatric patients (birth to less than 18 years old). • Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis, in adult and pediatric patients (birth to less than 18 years old). • Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP), in adult patients 18 years and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ZERBAXA