Drugs / budesonide/formoterol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed intermittent asthma 1 milestone | |||||
| Filed | EU (EMA) | Symbicort Turbuhaler | intermittent asthma | 2019-05-20 | “A regulatory submission to expand the indication for Symbicort Turbuhaler as an anti-inflammatory reliever in mild asthma has been accepted in Europe.” astrazeneca.com ↗ |
| Rejected asthma 1 milestone | |||||
| Rejected (CRL) | US (FDA) | SYMBICORT | asthma | 2009-04-06 | “AstraZeneca today announced the company has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for SYMBICORT” astrazeneca.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00542880 | Sep 2007 → Aug 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-08-28 | AstraZeneca | Results Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗
At the standard budesonide dose, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-01-26 | AstraZeneca | Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma astrazeneca.com ↗ |
| 2019-08-28 | AstraZeneca | Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗ |
| 2009-08-02 | AstraZeneca | AstraZeneca And Astellas Enter Agreement for Co-Promotion of Symbicort Turbuhaler in Japan astrazeneca.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | budesonide/formoterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00542880 ↗ |
| Known as | Symbicort Turbuhaler | “Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg” NCT00542880 ↗ |