PFIZERPEN (penicillin g potassium) · Pfizer
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.
Details
- Status
- Prescription
- First Approved
- 1968-08-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PFIZERPEN Approval History
What PFIZERPEN Treats
21 indicationsPFIZERPEN is approved for 21 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
- Botulism
- Gas Gangrene
- Tetanus
- Diphtheria
- Erysipelothrix Endocarditis
- Fusospirochetosis
- Listeria Infection
- Pasteurella Infection
- Haverhill Fever
- Rat-Bite Fever
- Disseminated Gonococcal Infection
- Syphilis
- Meningococcal Meningitis
PFIZERPEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.