Application Nr Approved Date Route Status External Links
ANDA208891 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Wixela™ Inhub™ Is A Combination Product Containing A Corticosteroid And A Long-Acting Beta 2 -Adrenergic Agonist (Laba) Indicated For: • Twice-Daily Treatment Of Asthma In Patients Aged 4 Years And Older. ( 1.1 ) • Maintenance Treatment Of Airflow Obstruction And Reducing Exacerbations In Patients With Chronic Obstructive Pulmonary Disease (Copd). ( 1.2 ) Important Limitation Of Use: Not Indicated For Relief Of Acute Bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment Of Asthma Wixela™ Inhub™ Is Indicated For The Twice-Daily Treatment Of Asthma In Patients Aged 4 Years And Older. Wixela™ Inhub™ Should Be Used For Patients Not Adequately Controlled On A Long-Term Asthma Control Medication Such As An Inhaled Corticosteroid (Ics) Or Whose Disease Warrants Initiation Of Treatment With Both An Ics And Long-Acting Beta 2 -Adrenergic Agonist (Laba). Important Limitation Of Use Wixela™ Inhub™ Is Not Indicated For The Relief Of Acute Bronchospasm. 1.2 Maintenance Treatment Of Chronic Obstructive Pulmonary Disease Wixela™ Inhub™ 250/50 Is Indicated For The Twice-Daily Maintenance Treatment Of Airflow Obstruction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And/or Emphysema. Wixela™ Inhub™ 250/50 Is Also Indicated To Reduce Exacerbations Of Copd In Patients With A History Of Exacerbations. Wixela™ Inhub™ 250/50 Twice Daily Is The Only Approved Dosage For The Treatment Of Copd Because An Efficacy Advantage Of The Higher Strength Wixela™ Inhub™ 500/50 Over Wixela™ Inhub™ 250/50 Has Not Been Demonstrated. Important Limitation Of Use Wixela™ Inhub™ Is Not Indicated For The Relief Of Acute Bronchospasm.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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