Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | HIV infectious disease | 2014-12-23 | “Marketing Authorization Applications in the European Union were fully validated on December 23, 2014 , and May 28, 2015 , for E/C/F/TAF and F/TAF respectively.” gilead.com ↗ “MAAs in the European Union were fully validated on December 23, 2014 , and August 20, 2015 , for E/C/F/TAF and R/F/TAF, respectively.” gilead.com ↗ “Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014 .” gilead.com ↗ “A Marketing Authorization Application (MAA) in the European Union for E/C/F/TAF was fully validated on December 23, 2014 .” gilead.com ↗ “Gilead's MAA for E/C/F/TAF was validated on December 23, 2014 .” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-11-05 | “In November 2014 , Gilead filed a New Drug Application (NDA) with the U.S. Food and Drug Administration ( FDA ) for E/C/F/TAF” gilead.com ↗ “Gilead filed a New Drug Application for E/C/F/TAF with the U.S. Food and Drug Administration on November 5, 2014.” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01797445 | Mar 2013 → Sep 2014 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2018-12-04 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-04-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. |
| 2016-04-04 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-03-01 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Odefsey ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. |
| 2016-02-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ |
All press releases naming this drug 6 releases
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 | E/C/F/TAF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01797445 ↗ |
| Route | Oral | “administered orally” NCT01797445 ↗ |