Drugs / Buprenorphine/naloxone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ZUBSOLV | opiate dependence | 2014-10-13 | “submitted an application to the U.S. Food and Drug Administration (FDA) for an expanded label of ZUBSOLV” orexo.com ↗ “submission of the New Drug Application for Zubsolv™ (buprenorphine/naloxone) in the USA.” orexo.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01908842 | Aug 2013 → Apr 2014 | opiate dependence | Orexo AB | 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 | Buprenorphine/naloxone | “Buprenorphine/naloxone sublingual tablets” NCT01908842 ↗ |