Drugs / Keppra XR
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | KEPPRA XR | — | 2014-08-01 – 2019-10-23 | fda.gov ↗ |
| Approved | US (FDA) | KEPPRA XR | — | 2008-09-12 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00419094 | Aug 2007 → Sep 2009 | epilepsy | UCB Pharma | Completed | Met primary |
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 | Keppra XR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00419094 ↗ |