PENICILLIN-VK (penicillin v potassium) · Teva
Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed.
Details
- Status
- Prescription
- First Approved
- 1968-07-03
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SOLUTION
PENICILLIN-VK Approval History
What PENICILLIN-VK Treats
10 indicationsPENICILLIN-VK is approved for 10 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
- Staphylococcal Infections
- Skin and Soft Tissue Infections
- Vincent's Gingivitis
- Pharyngitis
- Rheumatic Fever
- Chorea
PENICILLIN-VK 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
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Key Completed Trials
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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.
PENICILLIN-VK FDA Label Details
Indications & Usage
Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal inf...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.