Application Nr Approved Date Route Status External Links
NDA211109 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Xerava Is A Tetracycline Class Antibacterial Indicated For The Treatment Of Complicated Intra‑abdominal Infections In Patients 18 Years Of Age And Older. ( 1.1 ) Limitations Of Use Xerava Is Not Indicated For The Treatment Of Complicated Urinary Tract Infections (Cuti). ( 1.1 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Xerava And Other Antibacterial Drugs, Xerava Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. ( 1.2 ) 1.1 Complicated Intra-Abdominal Infections Xerava Is Indicated For The Treatment Of Complicated Intra‑abdominal Infections (Ciai) Caused By Susceptible Microorganisms: Escherichia Coli, Klebsiella Pneumoniae, Citrobacter Freundii, Enterobacter Cloacae, Klebsiella Oxytoca, Enterococcus Faecalis, Enterococcus Faecium, Staphylococcus Aureus, Streptococcus Anginosus Group, Clostridium Perfringens, Bacteroides Species, And Parabacteroides Distasonis In Patients 18 Years Or Older [See Microbiology ( 12.4 ) And Clinical Studies ( 14.1 )] . Limitations Of Use Xerava Is Not Indicated For The Treatment Of Complicated Urinary Tract Infections (Cuti) [See Clinical Studies ( 14.2 )] . 1.2 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Xerava And Other Antibacterial Drugs, Xerava Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Eravacycline Dihydrochloride ERAVACYCLINE DIHYDROCHLORIDE ZINC68246816

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