Drugs / Wellbutrin XL
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | WELLBUTRIN XL | — | 2006-06-12 | fda.gov ↗ |
| Approved | US (FDA) | WELLBUTRIN XL | — | 2003-08-28 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00439868 | Feb → Jun 2007 | depressive disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00616915 | Jan 2007 → Jan 2009 | mood disorder | Queen's University | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00456820 | Jul 2004 → Nov 2007 | depressive disorder, sexual disorder | Indiana University | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-05-05 | GlaxoSmithKline | GlaxoSmithKline to divest US rights for Wellbutrin XL® to Biovail for $510 million gsk.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | WELLBUTRIN XL | “WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.” NCT00439868 ↗ |
| Route | Oral | “receive oral doses” NCT00439868 ↗ |