Application Nr Approved Date Route Status External Links
NDA021912 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Brovana Inhalation Solution Is A Long-Acting Beta 2 -Adrenergic Agonist (Beta 2 -Agonist) Indicated For: Long-Term, Twice Daily (Morning And Evening) Administration In The Maintenance Treatment Of Bronchoconstriction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And Emphysema. ( 1.1 ) Important Limitations Of Use: Brovana Inhalation Solution Is Not Indicated To Treat Acute Deteriorations Of Chronic Obstructive Pulmonary Disease. ( 1.2 , 5.2 ) Brovana Inhalation Solution Is Not Indicated To Treat Asthma. ( 1.2 ) 1.1 Maintenance Treatment Of Copd Brovana (Arformoterol Tartrate) Inhalation Solution Is Indicated For The Long-Term, Twice Daily (Morning And Evening) Maintenance Treatment Of Bronchoconstriction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And Emphysema. Brovana Inhalation Solution Is For Use By Nebulization Only. 1.2 Important Limitations Of Use Brovana Inhalation Solution Is Not Indicated To Treat Acute Deteriorations Of Chronic Obstructive Pulmonary Disease [ See Warnings And Precautions ( 5.2 ) ]. Brovana Inhalation Solution Is Not Indicated To Treat Asthma. The Safety And Effectiveness Of Brovana Inhalation Solution In Asthma Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Arformoterol Tartrate ARFORMOTEROL TARTRATE ZINC895301

Comments