TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PFIZERPEN

PENICILLIN G POTASSIUM
Immunology Approved 1968-08-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
57
Years on Market

Details

Status
Prescription
First Approved
1968-08-30
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer
Active Ingredient: PENICILLIN G POTASSIUM

PFIZERPEN Approval History

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What PFIZERPEN Treats

10 indications

PFIZERPEN is approved for 10 conditions since its original approval in 1968. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Septicemia
  • Empyema
  • Pneumonia
  • Pericarditis
  • Endocarditis
  • Meningitis
  • Anthrax
  • Actinomycosis
Source: FDA Label

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Active Pipeline

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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.

PFIZERPEN FDA Label Details

Pro

Indications & Usage

Therapy Penicillin G Potassium for Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once th...

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Data Sources

FDA Approval: ANDA060657 → Label: DailyMed → Trials: ClinicalTrials.gov →

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