Drugs / Abacavir/Lamivudine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | HIV infectious disease | — | “single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the U.S. in October 2013.” gsk.com ↗ |
| Filed | Other | — | HIV infectious disease | — | “single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the U.S. in October 2013.” gsk.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | — | “single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the U.S. in October 2013.” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01608269 | Nov 2010 → Oct 2012 | HIV infectious disease | Therapeutic Concepts | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2012-07-11 | GlaxoSmithKline | Results Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV gsk.com ↗
The study demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla®. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2012-07-11 | GlaxoSmithKline | Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV gsk.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abacavir/Lamivudine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01608269 ↗ |
| Known as | Epzicom | “ABC/3TC (Epzicom), NRTI” NCT01608269 ↗ |