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Data updated: May 26, 2026

LIGNOSPAN FORTE (epinephrine bitartrate)

Other Approved 1986-01-14

Lignospan Forte is a combination of lidocaine hydrochloride (a local anesthetic) and epinephrine (a vasoconstrictor) used to provide local anesthesia for dental procedures. It is administered by dentists via nerve block or infiltration techniques. The addition of epinephrine helps prolong the duration of the anesthetic effect and provides local hemostasis (reduced bleeding) at the treatment site, ensuring patient comfort during standard or surgical dental work.

Source: FDA Label • DEPROCO

How LIGNOSPAN FORTE Works

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes (specifically sodium) required for the initiation and conduction of nerve impulses, thereby blocking the transmission of pain sensations. Epinephrine acts as a vasoconstrictor on alpha-adrenergic receptors, which decreases local blood flow. This delay in systemic absorption prolongs the duration of lidocaine's action and reduces the risk of systemic toxicity.

1
Indication
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1986-01-14
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

LIGNOSPAN FORTE Approval History

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Original
New Indication
New Form
Label Update
20 FDA actions from 1986 to 2025
Jun 2025 SUPPL
Mfg · Manufacturing (CMC)
Jun 2021 SUPPL
Label · Labeling
Nov 2018 SUPPL
Label · Labeling

What LIGNOSPAN FORTE Treats

1 indications

LIGNOSPAN FORTE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Local anesthesia for dental procedures
Source: FDA Label

LIGNOSPAN FORTE Competitive Set

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Drugs Similar to LIGNOSPAN FORTE

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CITANEST FORTE DENTAL
EPINEPHRINE BITARTRATE
1 shared
DENTSPLY PHARM
Shared indications:
Local anesthesia for dental procedures
LIGNOSPAN STANDARD
EPINEPHRINE BITARTRATE
1 shared
DEPROCO
Shared indications:
Local anesthesia for dental procedures
PRILOCAINE HYDROCHLORIDE
PRILOCAINE HYDROCHLORIDE
1 shared
SEPTODONT INC
Shared indications:
Local anesthesia for dental procedures
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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

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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.

LIGNOSPAN FORTE FDA Label Details

Indications & Usage

FDA Label (PDF)

LIGNOSPAN FORTE is indicated for the treatment of Local anesthesia for dental procedures.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.