Firvanq

Product manufactured by Cutispharma, Inc.

Application Nr Approved Date Route Status External Links
NDA208910 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Firvanq Is Indicated For The Treatment Of C Lostridium Difficil E-Associated Diarrhea In Adults And Pediatric Patients Less Than 18 Years Of Age. Firvanq Is Also Indicated For The Treatment Of Enterocolitis Caused By Staphylococcus Aureus (including Methicillin-Resistant Strains) In Adults And Pediatric Patients Less Than 18 Years Of Age. Important Limitations Of Use Parenteral Administration Of Vancomycin Is Not Effective For The Above Infections; Therefore, Vancomycin Must Be Given Orally For These Infections. Orally Administered Vancomycin Hydrochloride Is Not Effective For Treatment Of Other Types Of Infections. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Firvanq And Other Antibacterial Drugs, Firvanq 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. Firvanq Is A Glycopeptide Antibacterial Indicated In Adults And Pediatric Patients Less Than 18 Years Of Age For The Treatment Of: ( 1 ) Clostridiu M Difficile -Associated Diarrhea Enterocolitis Caused By Staphylococcus Aureus (including Methicillin-Resistant Strains) Important Limitations Of Use: ( 1 ) ( 5.1 ) Orally Administered Vancomycin Hydrochloride Is Not Effective For Treatment Of Other Types Of Infections. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Firvanq And Other Antibacterial Drugs, Firvanq Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Vancomycin Hydrochloride

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