ZINACEF (nda050558)- (EQ 1.5GM BASE/VIAL,EQ 7.5GM BASE/VIAL)

Generic Name	CEFUROXIME SODIUM	Innovator	PAI HOLDINGS PHARM
Dosage	EQ 1.5GM BASE/VIAL,EQ 7.5GM BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZINACEF isindicatedforthetreatmentofpatientswithinfectionscausedbysusceptiblestrains of the designated organisms in the following diseases: 1. Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilusinfluenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcusaureus(penicillinase-and non-penicillinase-producingstrains), Streptococcus pyogenes, and Escherichia coli. 2. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. 3. Skin and Skin-Structure Infections caused by Staphylococcus aureus(penicillinase-and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. 4. Septicemia caused by Staphylococcus aureus (penicillinase-and non-penicillinase-producing strains), Streptococcuspneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. 5. Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcusaureus (penicillinase-and non-penicillinase-producingstrains). 6. Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producingstrains) in both males and females. 7. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase-and nonpenicillinase-producingstrains).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1.5GM BASE/VIAL	**	**	-	-	-
EQ 7.5GM BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of ZINACEF