FDA · United States
ranolazine — FDA regulatory status
ranolazine (RANEXA (PREVIOUSLY LATIXA)) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- RANEXA (PREVIOUSLY LATIXA)
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Sodium channel protein type IV alpha subunit blocker
- Target
- Sodium channel protein type 4 subunit alpha
- Structured fields
- 6
Sponsor / originator context: Amneal Pharma Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Sodium channel protein type IV alpha subunit blocker. Target: Sodium channel protein type 4 subunit alpha. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 0 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Related hubs
FAQ
What is the FDA approval status of ranolazine?
ranolazine currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get ranolazine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.