Treats asthma. NDA 205625, held by Glaxosmithkline. Fluticasone Furoate.
As of Nov 14, 2026, NDA 205625 (Arnuity Ellipta), held by Glaxosmithkline, was first approved by FDA on Aug 20, 2014, with 5 approved supplements and 0 published complete response letters.
ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.
| Mar 1, 2023 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 17, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Aug 20, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Arnuity Ellipta0.1MG/INH · powder;inhalation | Fluticasone Furoate | RxReference drug |
| Arnuity Ellipta0.2MG/INH · powder;inhalation | Fluticasone Furoate | RxReference drug |
| Arnuity Ellipta0.05MG/INH · powder;inhalation | Fluticasone Furoate | RxReference drug |
| Oct 18, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Mar 1, 2023 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jan 7, 2019 | Supplement 7Labeling · Standard review | Approved | |
| May 17, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Aug 20, 2014 | Original applicationNew formulation or manufacturer · 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
