Bethkis

Product manufactured by Chiesi Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA201820 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bethkis Is Indicated For The Management Of Cystic Fibrosis Patients With Pseudomonas Aeruginosa . Safety And Efficacy Have Not Been Demonstrated In Patients Under The Age Of Six Years, Patients With Fev 1 Less Than 40% Or Greater Than 80% Predicted, Or Patients Colonized With Burkholderia Cepacia [S Ee Clinical Studies ( 14 )] . Bethkis Is An Inhaled Aminoglycoside Antibacterial Indicated For The Management Of Cystic Fibrosis Patients With Pseudomonas Aeruginosa . ( 1 ) Safety And Efficacy Have Not Been Demonstrated In Patients Under The Age Of Six Years, Patients With A Forced Expiratory Volume In One Second (Fev 1 ) Less Than 40% Or Greater Than 80% Predicted, Or Patients Colonized With Burkholderia Cepacia . ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tobramycin TOBRAMYCIN ZINC8214692

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