Application Nr Approved Date Route Status External Links
NDA208610 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Baxdela Is A Fluoroquinolone Antibacterial Indicated For The Treatment Of Adults With The Following Infections Caused By Designated Susceptible Bacteria: Acute Bacterial Skin And Skin Structure Infections (Absssi) ( 1.1 ) Community-Acquired Bacterial Pneumonia (Cabp) ( 1.2 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Baxdela And Other Antibacterial Drugs, Baxdela Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. ( 1.3 ) 1.1 Acute Bacterial Skin And Skin Structure Infections Baxdela Is Indicated In Adults For The Treatment Of Acute Bacterial Skin And Skin Structure Infections (Absssi) Caused By The Following Susceptible Microorganisms: Staphylococcus Aureus (Including Methicillin-Resistant [Mrsa] And Methicillin-Susceptible [Mssa] Isolates), Staphylococcus Haemolyticus, Staphylococcus Lugdunensis, Streptococcus Agalactiae , Streptococcus Anginosus Group (Including Streptococcus Anginosus , Streptococcus Intermedius , And Streptococcus Constellatus ), Streptococcus Pyogenes , Enterococcus Faecalis , Escherichia Coli, Enterobacter Cloacae, Klebsiella Pneumoniae, And Pseudomonas Aeruginosa. 1.2 Community-Acquired Bacterial Pneumonia Baxdela Is Indicated In Adults For The Treatment Of Community-Acquired Bacterial Pneumonia (Cabp) Caused By The Following Susceptible Microorganisms: Streptococcus Pneumoniae, Staphylococcus Aureus (Methicillin-Susceptible [Mssa] Isolates Only), Klebsiella Pneumoniae , Escherichia Coli, Pseudomonas Aeruginosa, Haemophilus Influenzae, Haemophilus Parainfluenzae , Chlamydia Pneumoniae , Legionella Pneumophila, And Mycoplasma Pneumoniae. 1.3 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Baxdela And Other Antibacterial Drugs, Baxdela 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. Delafloxacin Meglumine DELAFLOXACIN MEGLUMINE ZINC2020259

Comments