Bethkis

Product manufactured by Chiesi Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA201820 2012-10-12 Respiratory (inhalation) RX 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 Fev1 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 (fev1) 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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