Drugs / DynaHex-2
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DYNA-HEX 2 | — | 1989-12-27 – 2003-12-19 | fda.gov ↗ |
| Approved | US (FDA) | DYNA-HEX 2 | — | 1985-12-17 | fda.gov ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT02526667 Comparator | Aug → Dec 2015 | — | Medline Industries | Completed | No outcome recorded |
| Phase 3 | NCT02291601 Comparator | Oct 2014 → Sep 2015 | — | Medline Industries | Completed | No outcome recorded |
| Phase 3 | NCT02222896 Comparator | Aug → Nov 2014 | — | Medline Industries | Completed | No outcome recorded |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DynaHex-2 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02222896 ↗ |