Drugs / Actonel
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | ACTONEL | — | 2000-04-14 – 2009-07-23 | fda.gov ↗ |
| Approved | US (FDA) | ACTONEL | — | 1998-03-27 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT00616694 | Jul 2002 → Dec 2004 | osteoporosis | Sanofi | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT00919711 Comparator | Sep 2009 → Dec 2011 | osteoporosis | Amgen | Completed | Met primary |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Actonel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00919711 ↗ |
| Route | Oral | “Actonel 5 mg orally once daily (OD)” NCT00616694 ↗ |