Overview
Cefditoren is an oral third-generation cephalosporin. It is commonly marketed under the trade name Spectracef by Cornerstone BioPharma.
Background
Cefditoren is an oral third-generation cephalosporin. It is commonly marketed under the trade name Spectracef by Cornerstone BioPharma.
Indication
For the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of microorganisms in acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, pharyngitis/tonsillitis, and uncomplicated skin and skin-structure infections.
Associated Conditions
- Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
- Bacterial Infections
- Community Acquired Pneumonia (CAP)
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Uncomplicated skin and subcutaneous tissue bacterial infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/16 | Not Applicable | Completed | West China Second University Hospital | ||
2021/01/14 | Phase 4 | Completed | Meiji Pharma Spain S.A. | ||
2012/03/13 | Phase 4 | UNKNOWN | |||
2008/01/21 | Phase 3 | Completed | Tedec-Meiji Farma, S.A. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Vansen Pharma Inc. | 44004-802 | ORAL | 400 mg in 1 1 | 2/19/2013 | |
| Pharma RomLev Inc. | 44009-802 | ORAL | 400 mg in 1 1 | 2/19/2013 | |
| Vansen Pharma Inc. | 44004-801 | ORAL | 200 mg in 1 1 | 2/19/2013 | |
| Pharma RomLev Inc. | 44009-801 | ORAL | 200 mg in 1 1 | 2/19/2013 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefditoren Pivoxil Granules | 国药准字HJ20150211 | 化学药品 | 颗粒剂 | 8/28/2020 | |
| Cefditoren Pivoxil Granules | 国药准字HJ20150417 | 化学药品 | 颗粒剂 | 8/28/2020 | |
| Cefditoren Pivoxil Granules | 国药准字HJ20150212 | 化学药品 | 颗粒剂 | 8/28/2020 | |
| Cefditoren Pivoxil Granules | 国药准字HJ20150470 | 化学药品 | 颗粒剂 | 8/28/2020 | |
| Cefditoren Pivoxil Tablets | 国药准字HJ20150234 | 化学药品 | 片剂 | 7/24/2020 | |
| Cefditoren Pivoxil Tablets | 国药准字HJ20150235 | 化学药品 | 片剂 | 7/24/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||