Drugs / Seroquel XR
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | SEROQUEL XR | — | 2008-10-08 – 2013-04-30 | fda.gov ↗ |
| Approved | US (FDA) | SEROQUEL XR | — | 2007-05-17 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not applicable1 trial | ||||||
| — | NCT01066143 | Feb 2010 → Feb 2013 | generalized anxiety disorder | Mclean Hospital | Terminated | No outcome recorded Stop: Business |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT01727726 Comparator | Dec 2012 → Oct 2016 | major depressive disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Seroquel XR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01066143 ↗ |