TheraRadar
Data updated: May 26, 2026

AMTURNIDE (aliskiren hemifumarate)

Cardiovascular Approved 2010-12-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Discontinued
First Approved
2010-12-21
Routes
ORAL
Dosage Forms
TABLET

Companies

Novartis
Active Ingredient: ALISKIREN HEMIFUMARATE , AMLODIPINE BESYLATE , HYDROCHLOROTHIAZIDE

AMTURNIDE Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
75 FDA actions from 2010 to 2016
Nov 2016 SUPPL
Label · Labeling
FDA Letter Label
Dec 2015 SUPPL
Label · Labeling
FDA Letter Label
Mar 2015 SUPPL
Label · Labeling
FDA Letter Label

What AMTURNIDE Treats

1 FDA approvals

Originally approved for its first indication in 2010 .

  • Other (1)
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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.

AMTURNIDE FDA Label Details

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Data Sources

FDA Approval: NDA200045 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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