Lowers the risk of COPD exacerbations. NDA 22522, held by Astrazeneca. Roflumilast.
As of Nov 14, 2026, NDA 22522 (Daliresp), held by Astrazeneca, was first approved by FDA on Feb 28, 2011, with 8 approved supplements and 0 published complete response letters.
DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
| Jan 23, 2018 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Aug 31, 2017 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2011 | Original applicationNew molecular entity · Standard review | Approved |
| Daliresp500MCG · tablet;oral | Roflumilast | RxReference drug |
| Daliresp250MCG · tablet;oral | Roflumilast | RxReference drug |
| Jan 23, 2018 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Aug 31, 2017 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 12, 2016 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 24, 2015 | Supplement 6Labeling · Standard review | Approved | |
| Sep 17, 2014 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 23, 2013 | Supplement 3Labeling · Standard review | Approved | |
| Dec 18, 2012 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2012 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 28, 2011 | Original applicationNew molecular entity · Standard review | Approved |
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
