fluticasone furoate, umeclidinium bromide and vilanterol trifenatate

FDA Drug Profile — Trelegy Ellipta

Drug Details

Generic Name
fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
Brand Names
Trelegy Ellipta
Application Number
NDA209482
Sponsor
GlaxoSmithKline LLC
NDC Codes
2
Dosage Forms
POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE

Indications and Usage

1 INDICATIONS AND USAGE TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) • the maintenance treatment of asthma in patients aged 18 years and older. ( 1.2 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1.3 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma TRELEGY ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 18 years and older. 1.3 Limitations of Use TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm.