TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PENICILLIN-VK

PENICILLIN V POTASSIUM
Immunology Approved 1968-07-03
2
Indications
--
Phase 3 Trials
57
Years on Market

Details

Status
Prescription
First Approved
1968-07-03
Routes
ORAL
Dosage Forms
TABLET, FOR SOLUTION

Companies

Active Ingredient: PENICILLIN V POTASSIUM

PENICILLIN-VK Approval History

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What PENICILLIN-VK Treats

4 indications

PENICILLIN-VK is approved for 4 conditions since its original approval in 1968. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Streptococcal Infections
  • Scarlet Fever
  • Erysipelas
  • Pneumococcal Infections
Source: FDA Label
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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

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.

PENICILLIN-VK FDA Label Details

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Indications & Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V potassium tablets are indicated in...

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Data Sources

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