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cefdinir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| cefdinir | DRUG | cefdinir oral suspension, 25 mg/kg once daily for 10 days |
Inclusion Criteria: * Male and female children between 6 months and 4 years of age * Weight does not exceed 40 kg * Clinical diagnosis is acute otitis media * Have evidence of middle ear fluid * At risk for persistent or recurrent otitis media * Generally in good health Exclusion Criteria: * Sens...
Cefdinir is an investigational small molecule being studied for the treatment of acute otitis media, an ear infection common in children. It is formulated as an oral suspension for pediatric use. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
Cefdinir is being developed by Abbott Laboratories, a company publicly traded under the ticker symbol ABT. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating acute otitis media in pediatric patients.
Cefdinir is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 2 trial for cefdinir has been completed, and the drug is being studied for the treatment of acute otitis media in children.
Cefdinir has one completed clinical trial registered under NCT00645203, titled "Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media." The Phase 2 study enrolled 447 participants across the United States, Chile, Costa Rica, Dominican Republic, Guatemala, Israel, and Panama.
Cefdinir is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of acute otitis media. The drug has completed one clinical trial, but it remains under investigation and has not been authorized for commercial use.