Drugs / Evotaz®
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Evotaz | — | 2015-07-13 | europa.eu ↗ |
| Approved | US (FDA) | EVOTAZ | — | 2015-01-29 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02697851 | Jul 2016 → Oct 2017 | HIV infectious disease | St Stephens Aids Trust | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2015-07-16 | Bristol-Myers Squibb | Regulatory European Commission Approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat fixed-dose combination) for the Treatment of HIV-1 Infection in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. |
| 2015-01-29 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Bristol-Myers Squibb’s Evotaz™ (atazanavir and cobicistat) for the Treatment of HIV-1 Infection in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-07-16 | Bristol-Myers Squibb | European Commission Approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat fixed-dose combination) for the Treatment of HIV-1 Infection in Adults bms.com ↗ |
| 2015-01-29 | Bristol-Myers Squibb | U.S. Food and Drug Administration Approves Bristol-Myers Squibb’s Evotaz™ (atazanavir and cobicistat) for the Treatment of HIV-1 Infection in Adults bms.com ↗ |
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 | Evotaz | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02697851 ↗ |