TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NEUROLITE

TECHNETIUM TC-99M BICISATE KIT
Approved 1994-11-23
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1994-11-23
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

LANTHEUS MEDCL
Active Ingredient: TECHNETIUM TC-99M BICISATE KIT

NEUROLITE Approval History

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What NEUROLITE Treats

1 indications

NEUROLITE is approved for 1 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Stroke
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

NEUROLITE FDA Label Details

Pro

Indications & Usage

INDICATIONS Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.

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Data Sources

FDA Approval: NDA020256 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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