Drugs / LDV/SOF
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | hepatitis C genotype 1 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 ↗ |
| Filed | US (FDA) | — | hepatitis C genotype 1 infection | 2014-02-10 | “On February 10, 2014 , Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for the LDV/SOF fixed-dose combination tablet” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01260350 | Dec 2010 → Oct 2013 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
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 | LDV/SOF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01260350 ↗ |