TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EXEMESTANE

EXEMESTANE
Approved 2011-04-01
Jump to: Indications Approvals Trials Competitors Safety Patents
11
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2011-04-01
Routes
ORAL
Dosage Forms
TABLET

Companies

Hikma RISING AMNEAL PHARMS Dr. Reddy's ZYDUS PHARMS Cipla EUGIA PHARMA ALVOGEN UPSHER SMITH LABS QILU BRECKENRIDGE
Active Ingredient: EXEMESTANE

EXEMESTANE Approval History

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What EXEMESTANE Treats

11 FDA approvals

Originally approved for its first indication in 2011 . Covers 11 distinct patient populations.

  • Other (11)
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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.

EXEMESTANE FDA Label Details

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Data Sources

FDA Approval: ANDA077431 → Trials: ClinicalTrials.gov →

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