Drugs / Qudexy XR
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | QUDEXY XR | — | 2015-03-30 – 2017-03-29 | fda.gov ↗ |
| Approved | US (FDA) | QUDEXY XR | — | 2014-03-11 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04748601 | Feb 2021 → Sep 2026 overdue | migraine disorder | Upsher-Smith Laboratories | Recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-08-21 | Upsher-Smith Laboratories | Upsher-Smith Launches Newly Designed Website for Qudexy XR (topiramate) Extended-Release Capsules upsher-smith.com ↗ |
| 2017-03-30 | Upsher-Smith Laboratories | FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules upsher-smith.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Qudexy XR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04748601 ↗ |