ERTAPENEM SODIUM
ERTAPENEM SODIUM is indicated for the treatment of Intra-Abdominal Infections; Skin and Skin Structure Infections; Diabetic Foot Infections; Community-Acquired Pneumonia; Urinary Tract Infections; Pyelonephritis; Pelvic Infections; Postpartum Endomyometritis; Septic Abortion; Surgical Site Infection.
How ERTAPENEM SODIUM Works
Ertapenem is a carbapenem antibiotic that exerts bactericidal activity by binding to penicillin-binding proteins (PBPs), which results in the inhibition of bacterial cell wall synthesis.
Details
- Status
- Prescription
- First Approved
- 2018-04-16
- Routes
- INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE
ERTAPENEM SODIUM Approval History
What ERTAPENEM SODIUM Treats
10 indicationsERTAPENEM SODIUM is approved for 10 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Intra-Abdominal Infections
- Skin and Skin Structure Infections
- Diabetic Foot Infections
- Community-Acquired Pneumonia
- Urinary Tract Infections
- Pyelonephritis
- Pelvic Infections
- Postpartum Endomyometritis
ERTAPENEM SODIUM 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.
Drugs Similar to ERTAPENEM SODIUM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01370616 results posted | 0826-061 | Ph 3 | completed | Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061) |
| NCT01254344 results posted | 0826-056 | Ph 3 | completed | Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056) |
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.
ERTAPENEM SODIUM FDA Label Details
Indications & Usage
ERTAPENEM SODIUM is indicated for the treatment of Intra-Abdominal Infections; Skin and Skin Structure Infections; Diabetic Foot Infections; Community-Acquired Pneumonia; Urinary Tract Infections; Pyelonephritis; Pelvic Infections; Postpartum Endomyometritis; Septic Abortion; Surgical Site Infection.
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INVANZ
Full clinical data, patents, trials, and competitive landscape for ertapenem sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.