TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PANRETIN

ALITRETINOIN
Oncology Approved 1999-02-02
1
Indication
--
Phase 3 Trials
1
Priority Reviews
27
Years on Market

Details

Status
Prescription
First Approved
1999-02-02
Routes
TOPICAL
Dosage Forms
GEL

Companies

Active Ingredient: ALITRETINOIN

PANRETIN Approval History

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What PANRETIN Treats

1 indications

PANRETIN is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Kaposi's Sarcoma
Source: FDA Label

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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

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.

PANRETIN FDA Label Details

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Indications & Usage

FDA Label (PDF)

1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when syst...

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Data Sources

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