TheraRadar
Data updated: May 26, 2026

AXERT (almotriptan malate)

CNS Approved 2001-05-07
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
25
Years on Market

Details

Status
Discontinued
First Approved
2001-05-07
Routes
ORAL
Dosage Forms
TABLET

Companies

Johnson & Johnson
Active Ingredient: ALMOTRIPTAN MALATE

AXERT Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2001 to 2017 · 1 indication expansions
May 2017 SUPPL
Label · Labeling
FDA Letter Label
Aug 2014 SUPPL
Label · Labeling
FDA Letter Label
Apr 2009 SUPPL Priority
Efficacy
Label

What AXERT Treats

2 FDA approvals

Originally approved for its first indication in 2001 . Covers 2 distinct patient populations.

  • Other (2)
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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.

AXERT FDA Label Details

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Data Sources

FDA Approval: NDA021001 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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