fluticasone furoate and vilanterol trifenatate
Drug Details
- Generic Name
- fluticasone furoate and vilanterol trifenatate
- Brand Names
- Breo Ellipta
- Application Number
- NDA204275
- Sponsor
- GlaxoSmithKline LLC
- NDC Codes
- 3
- Dosage Forms
- POWDER
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FLUTICASONE FUROATE, VILANTEROL TRIFENATATE
Indications and Usage
1 INDICATIONS AND USAGE BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, 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 5 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 BREO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma BREO ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older. 1.3 Limitations of Use BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.