TheraRadar
Data updated: Sep 20, 2026

Hemofil M (antihemophilic factor (human)) · Takeda

Approved 2001-03-13
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
25
Years on Market

Details

Status
Prescription
First Approved
2001-03-13
Routes
Intravenous
Dosage Forms
For Injection

Companies

Takeda
Active Ingredient: Antihemophilic Factor (Human) , Antihemophilic Factor (Human) , Antihemophilic Factor (Human) , Antihemophilic Factor (Human)

Hemofil M Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
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2020
2021
2022
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2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2001 to 2001
Mar 2001 ORIGINAL
Update · CBER biologic (Purple Book)

What Hemofil M Treats

1 FDA approvals

Originally approved for its first indication in 2001 .

  • Other (1)
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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.

Hemofil M FDA Label Details

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Data Sources

FDA Approval: BLA101448 → Trials: ClinicalTrials.gov →

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