INVANZ (ertapenem sodium) · Merck
Invanz is a carbapenem antibacterial indicated for the treatment of moderate to severe infections in adults and pediatric patients (3 months of age and older). It is used to treat complicated intra-abdominal infections, skin and skin structure infections (including diabetic foot infections without osteomyelitis), and complicated urinary tract infections (including pyelonephritis). It is also indicated for community-acquired pneumonia and acute pelvic infections. In adult patients, Invanz is indicated for the prophylaxis of surgical site infections following elective colorectal surgery. To prevent the development of drug-resistant bacteria, its use should be limited to infections proven or strongly suspected to be caused by susceptible bacteria.
How INVANZ Works
Ertapenem is a carbapenem antibiotic that exerts bactericidal activity by binding to penicillin-binding proteins (PBPs). This binding inhibits the transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to the interruption of cell wall assembly and subsequent bacterial cell lysis.
Details
- Status
- Prescription
- First Approved
- 2001-11-21
- Routes
- INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE
INVANZ Approval History
What INVANZ Treats
10 indicationsINVANZ is approved for 10 conditions since its original approval in 2001. 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
- Septic Abortion
- Surgical Site Infection
INVANZ 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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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.
INVANZ FDA Label Details
Indications & Usage
FDA Label (PDF)INVANZ is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. Community-acquired pneumonia. Complicated urinary tract infections including pyelonephritis. Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. INVANZ is indicated in adults for...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.