CEFDINIR · ALKEM LABS LTD
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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.
Details
- Status
- Prescription
- First Approved
- 1997-12-04
- Routes
- ORAL
- Dosage Forms
- CAPSULE, FOR SUSPENSION
CEFDINIR Approval History
What CEFDINIR Treats
7 indicationsCEFDINIR is approved for 7 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Community-Acquired Pneumonia
- Acute Exacerbations of Chronic Bronchitis
- Acute Maxillary Sinusitis
- Pharyngitis
- Tonsillitis
- Uncomplicated Skin and Skin Structure Infections
- Acute Bacterial Otitis Media
CEFDINIR 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 CEFDINIR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02891915 results posted | 14-0079 HHSN272201300023I | Ph 4 | completed | Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children |
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.
CEFDINIR FDA Label Details
Indications & Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension is indicated for the treatment of patients wit...
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OMNICEF
Full clinical data, patents, trials, and competitive landscape for cefdinir.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.