TheraRadar
Data updated: May 26, 2026

Raplixa (fibrin sealant (human))

Approved 2015-04-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Disc
First Approved
2015-04-29
Routes
Topical
Dosage Forms
Powder

Companies

Mallinckrodt Pharma IP Trading DAC
Active Ingredient: Fibrin Sealant (Human) , Fibrin Sealant (Human) , Fibrin Sealant (Human)

Raplixa Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2015 to 2015
Apr 2015 ORIGINAL
Update · CBER biologic (Purple Book)

What Raplixa Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02117349 results posted FC-007 Ph 2 terminated Topical Raplixa for Surgical Bleeding in Children
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

Raplixa FDA Label Details

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Data Sources

FDA Approval: BLA125523 → Trials: ClinicalTrials.gov →

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