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Data updated: Mar 10, 2026

PENTAMIDINE ISETHIONATE

PENTAMIDINE ISETHIONATE
Oncology Approved 1992-06-30
8
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Prescription
First Approved
1992-06-30
Routes
INHALATION, INJECTION
Dosage Forms
FOR SOLUTION, INJECTABLE

PENTAMIDINE ISETHIONATE Approval History

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What PENTAMIDINE ISETHIONATE Treats

2 indications

PENTAMIDINE ISETHIONATE is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pneumocystis jiroveci Pneumonia
  • Kaposi's Sarcoma
Source: FDA Label

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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.

PENTAMIDINE ISETHIONATE FDA Label Details

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Indications & Usage

Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had...

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Data Sources

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