Fluticasone/Umeclidinium/Vilanterol Inhalation Powder | Study Design

Fluticasone/Umeclidinium/Vilanterol Orally Inhaled Product FDA – BE Study Design

 

Regulatory Body FDA
Study Drug Information Test Product Reference Product
Strength Fluticasone furoate / Umeclidinium /
Vilanterol
100/62.5/25 mcg
200/62.5/25 mcg
TRELEGY ELLIPTA
100/62.5/25 mcg
200/62.5/25 mcg
Formulation Inhalation powder Inhalation powder
Manufacturer Any Sponsor GSK
Route Oral Inhalation Oral Inhalation
Therapeutic Indication Therapeutic class: Respiratory
Drug class:
• Fluticasone furoate: inhaled corticosteroid (ICS)
• Umeclidinium: anticholinergic
• Vilanterol: a long-acting β2 agonist (LABA)
Therapeutic indication: Asthma, or severe COPD

 

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