umeclidinium bromide and vilanterol trifenatate
Drug Details
- Generic Name
- umeclidinium bromide and vilanterol trifenatate
- Brand Names
- Umeclidinium and Vilanterol Ellipta, Anoro Ellipta
- Application Number
- NDA203975
- Sponsor
- Prasco Laboratories
- NDC Codes
- 2
- Dosage Forms
- POWDER
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE
Indications and Usage
1 INDICATIONS AND USAGE Umeclidinium and Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use Umeclidinium and Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of Umeclidinium and Vilanterol ELLIPTA in asthma have not been established. Umeclidinium and Vilanterol ELLIPTA is a combination of 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 ) Limitations of Use: Not indicated for relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.2 )