TheraRadar
Data updated: Nov 8, 2026

AMERGE (naratriptan hydrochloride) · GSK

Pain Approved 1998-02-10
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1998-02-10
Routes
ORAL
Dosage Forms
TABLET

Companies

GSK
Active Ingredient: NARATRIPTAN HYDROCHLORIDE

AMERGE Approval History

1999
2000
2001
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
22 FDA actions from 1998 to 2016
Nov 2016 SUPPL
Label · Labeling
FDA Letter Label
Oct 2013 SUPPL
Label · Labeling
FDA Letter Label
Mar 2012 SUPPL
Label · Labeling
FDA Letter Label

What AMERGE Treats

1 FDA approvals

Originally approved for its first indication in 1998 .

  • 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.

AMERGE FDA Label Details

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Data Sources

FDA Approval: NDA020763 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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