Treats bronchospasm associated with chronic obstructive pulmonary disease (COPD). NDA 207070, held by Boehringer Ingelheim. Tiotropium Bromide.
As of Nov 15, 2026, NDA 207070 (Spiriva Respimat), held by Boehringer Ingelheim, was first approved by FDA on Sep 15, 2015, with 0 approved supplements and 0 published complete response letters.
SPIRIVA RESPIMAT is an anticholinergic indicated for: The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older Limitation of Use: Not indicated for relief of acute bronchospasm ( 1.1, 1.2, 5.1 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease SPIRIVA RESPIMAT (tiotropium bromide) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2015 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Spiriva Respimat2.5MCG · spray;inhalation | Tiotropium Bromide | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
