PIPERACILLIN (piperacillin sodium) · ISTITUTO BIO ITA SPA
Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older Nosocomial pneumonia in adult and pediatric patients 2 months of age and older Skin and skin structure infections in adults Female pelvic infections in adults Community-acquired pneumonia in adults To reduce t...
Details
- Status
- Prescription
- First Approved
- 2003-11-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PIPERACILLIN Approval History
What PIPERACILLIN Treats
7 indicationsPIPERACILLIN is approved for 7 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Intra-abdominal Infections
- Nosocomial Pneumonia
- Skin and Skin Structure Infections
- Female Pelvic Infections
- Community-Acquired Pneumonia
- Appendicitis
- Peritonitis
PIPERACILLIN 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 PIPERACILLIN
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 |
|---|---|---|---|---|
| NCT02493764 RESTORE-IMI 2 results posted | 7655A-014 2015-000246-34, 163240 | Ph 3 | completed | Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) |
| NCT00894439 | 3219K1-1002 | Ph 1 | completed | Study Evaluating BLI-489 and Piperacillin in Healthy Subjects |
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.
PIPERACILLIN FDA Label Details
Indications & Usage
Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older Nosocomial pneumonia in adult and pediatric patients 2 months of age and older Skin and skin structure infections in adults Female pelvic infections in adults Community-acquired pneumonia in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and tazobac...
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PIPRACIL
Full clinical data, patents, trials, and competitive landscape for piperacillin sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.