fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
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.