Glycopyrrolate and formoterol fumarate
Drug Details
- Generic Name
- Glycopyrrolate and formoterol fumarate
- Brand Names
- BEVESPI AEROSPHERE
- Application Number
- NDA208294
- Sponsor
- AstraZeneca Pharmaceuticals LP
- NDC Codes
- 1
- Dosage Forms
- AEROSOL, METERED
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FORMOTEROL FUMARATE, GLYCOPYRROLATE
Indications and Usage
1 INDICATIONS AND USAGE BEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.2 )] . BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, 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 the relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.1 , 5.2 )