Drugs / budesonide/formoterol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Symbicort Turbuhaler | 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 (CRL) | US (FDA) | SYMBICORT | asthma | 2009-04-06 | “received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for SYMBICORT” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | Symbicort Turbuhaler | asthma | — | “Symbicort Turbuhaler is not currently available in Japan. AstraZeneca submitted a new drug application (NDA) in Japan in May, 2007.” astrazeneca.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01415518 | Sep 2011 → Dec 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-05-17 | AstraZeneca | Results New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma astrazeneca.com ↗
Both trials met their primary efficacy outcomes. |
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 ↗ |
| 2018-05-17 | AstraZeneca | New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma astrazeneca.com ↗ |
| 2009-08-02 | AstraZeneca | AstraZeneca And Astellas Enter Agreement for Co-Promotion of Symbicort Turbuhaler in Japan astrazeneca.com ↗ |
Evidence & citations 3 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 NCT01415518 ↗ |
| Known as | Symbicort Turbuhaler | “budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)” NCT01415518 ↗ |
| Route | Inhaled | “2 inhalations twice daily” NCT01415518 ↗ |