TheraRadar
Data updated: May 26, 2026

NEUROLITE (technetium tc-99m bicisate kit)

Cardiovascular Approved 1994-11-23

NEUROLITE is indicated for the treatment of Stroke.

Source: FDA Label • SHINE
1
Indication
--
Phase 3 Trials
31
Years on Market

Details

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

Companies

Active Ingredient: TECHNETIUM TC-99M BICISATE KIT

NEUROLITE Approval History

1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
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2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 1994 to 2015
Feb 2015 SUPPL
Mfg · Manufacturing (CMC)
May 2000 SUPPL
Mfg · Manufacturing (CMC)
Feb 2000 SUPPL
Label · Labeling

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

NEUROLITE Competitive Set

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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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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

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

Indications & Usage

NEUROLITE is indicated for the treatment of Stroke.

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Data Sources

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