Drugs / budesonide/formoterol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 2 milestones | |||||
| 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 ↗ |
| 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 ↗ |
| 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 ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00421122 | Sep 2006 → Nov 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2021-03-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Inc. and Kindeva Drug Delivery Announce FDA Tentative Approval of the First Abbreviated New Drug Application Generic Version of Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol viatris.com ↗
today announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort ® based on an Abbreviated New Drug Application (ANDA). |
| 2016-09-06 | GlaxoSmithKline | Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗
In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001). |
| 2016-06-20 | GlaxoSmithKline | Results FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.com ↗ |
All press releases naming this drug 15 releases
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 NCT00421122 ↗ |
| Known as | Symbicort | “budesonide/formoterol (Symbicort)” NCT00421122 ↗ |
| Route | Inhaled | “inhalation therapy” NCT00421122 ↗ |