Drugs / Buprenorphine/naloxone
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00637000 | Mar → Sep 2008 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-06-18 | Indivior Inc. | Regulatory Indivior | Indivior Announces Validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for SUBOXONE (buprenorphine and naloxone) Sublingual Film indivior.com ↗
Indivior PLC (LON: INDV) (the ‘Company’), a global specialty pharmaceutical company with a 20-year legacy of leadership in developing medicines to treat opioid use disorder (OUD), today announced that the European Medicines Agency (EMA) has completed formal validation of Indivior’s Marketing Authorization Application (MAA) for SUBOXONE Film. |
| 2018-06-15 | Indivior Inc. | Regulatory Indivior | Indivior Responds to Generic SUBOXONE® Approvals and Dr. Reddy’s Launch “At-Risk” indivior.com ↗
the US FDA approved generic versions of SUBOXONE® Film from both Dr. Reddy’s and Mylan |
All press releases naming this drug 2 releases
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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00637000 ↗ |