PRILOCAINE HYDROCHLORIDE
Prilocaine Hydrochloride helps patients undergoing dental procedures by providing local anesthesia. It is used during nerve blocks or infiltration techniques to numb specific areas of the mouth. This medication allows dental professionals to perform standard procedures while ensuring the patient remains comfortable in the targeted area.
How PRILOCAINE HYDROCHLORIDE Works
This drug works by stabilizing the neuronal membrane to prevent the start and spread of nerve impulses. It achieves this by blocking the movement of ions that are necessary for the nerves to send signals. By stopping these electrical impulses, the medication effectively creates a local anesthetic effect.
Details
- Status
- Prescription
- First Approved
- 2010-09-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PRILOCAINE HYDROCHLORIDE Approval History
What PRILOCAINE HYDROCHLORIDE Treats
2 indicationsPRILOCAINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Local anesthesia for dental procedures
- Nerve block and infiltration in dentistry
PRILOCAINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRILOCAINE HYDROCHLORIDE FDA Label Details
Indications & Usage
PRILOCAINE HYDROCHLORIDE is indicated for the treatment of Local anesthesia for dental procedures; Nerve block and infiltration in dentistry.
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Full clinical data, patents, trials, and competitive landscape for prilocaine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.