Drugs / LDV/SOF
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2014-02-27 | “Announced that the company’s Marketing Authorisation Application for LDV/SOF has been fully validated and is now under assessment by the European Medicines Agency” gilead.com ↗ “A marketing application for LDV/SOF is also under review in the European Union , and was validated by the European Medicines Agency (EMA) on March 27, 2014” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2014-02-10 | “Gilead filed the NDA for LDV/SOF on February 10, 2014” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02738333 | Apr 2016 → Feb 2017 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
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 | LDV/SOF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02738333 ↗ |
| Route | Oral | “90/400 mg FDC tablet administered orally once daily” NCT02738333 ↗ |