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EMBLAVEO (NDA217906)- (EQ 0.5GM BASE/VIAL;1.5GM/VIAL)

AVIBACTAM SODIUM; AZTREONAM ABBVIE
EQ 0.5GM BASE/VIAL;1.5GM/VIAL
No Yes
2032-Jun-15 Expired
None None
None No
EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 0.5GM BASE/VIAL;1.5GM/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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