Altabax

Product manufactured by Almirall, Llc

Application Nr Approved Date Route Status External Links
NDA022055 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Altabax ® Is Indicated For Use In Adults And Pediatric Patients Aged 9 Months And Older For The Topical Treatment Of Impetigo (Up To 100 Cm 2 In Total Area In Adults Or 2% Total Body Surface Area In Pediatric Patients Aged 9 Months Or Older) Due To Staphylococcus Aureus (Methicillin-Susceptible Isolates Only) Or Streptococcus Pyogenes [See Clinical Studies ( 14 )] . Safety In Patients Younger Than 9 Months Has Not Been Established. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Altabax And Other Antibacterial Drugs, Altabax Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. Altabax, A Pleuromutilin Antibacterial, Is Indicated For The Topical Treatment Of Impetigo Due To Staphylococcus Aureus (Methicillin-Susceptible Isolates Only) Or Streptococcus Pyogenes In Patients Aged 9 Months Or Older. ( 1 ) Safety In Patients Younger Than 9 Months Has Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Retapamulin RETAPAMULIN ZINC101456635

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