olodaterol respimat inhalation spray
Drug Details
- Generic Name
- olodaterol respimat inhalation spray
- Brand Names
- Striverdi Respimat
- Application Number
- NDA203108
- Sponsor
- Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC Codes
- 1
- Dosage Forms
- SPRAY, METERED
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- OLODATEROL HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE STRIVERDI RESPIMAT Inhalation Spray is a long-acting beta 2 -adrenergic agonist (LABA) indicated for: The long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ( 1.1 ) Important limitations: STRIVERDI RESPIMAT is NOT indicated to treat acute deterioration of COPD. ( 1.2 ) STRIVERDI RESPIMAT is NOT indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD STRIVERDI RESPIMAT is a long-acting beta 2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 1.2 Important Limitations of Use STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2) ] . STRIVERDI RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STRIVERDI RESPIMAT in asthma have not been established.