Application Nr Approved Date Route Status External Links
NDA021883 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indication S And Usage Dalvance Is Indicated For Acute Bacterial Skin And Skin Structure Infections (Absssi) Caused By Designated Susceptible Strains Of Gram-Positive Microorganisms. ( 1.1 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Dalvance And Other Antibacterial Drugs, Dalvance Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. ( 1.2 ) 1.1 Acute Bacterial Skin And Skin Structure Infections Dalvance ® (Dalbavancin) For Injection Is Indicated For The Treatment Of Adult Patients With Acute Bacterial Skin And Skin Structure Infections (Absssi), Caused By Susceptible Isolates Of The Following Gram-Positive Microorganisms: Staphylococcus Aureus (Including Methicillin-Susceptible And Methicillin-Resistant Strains), Streptococcus Pyogenes , Streptococcus Agalactiae , Streptococcus Dys Galactiae , Streptococcus Anginosus Group (Including S . Anginosus, S . Interm E Dius, S . Constellatus ) And Enterococcus Faecalis (Vancomycin Susceptible Strains) . 1.2 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Dalvance And Other Antibacterial Agents, Dalvance Should Be Used Only To Treat 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. Dalbavancin Hydrochloride

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