fluticasone furoate and vilanterol
Drug Details
- Generic Name
- fluticasone furoate and vilanterol
- Brand Names
- Fluticasone Furoate and Vilanterol
- Application Number
- NDA204275
- Sponsor
- Prasco Laboratories
- NDC Codes
- 2
- Dosage Forms
- POWDER
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FLUTICASONE FUROATE, VILANTEROL TRIFENATATE
Indications and Usage
1 INDICATIONS AND USAGE Fluticasone Furoate/Vilanterol 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 Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older. 1.3 Limitations of Use Fluticasone Furoate/Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm.