Drugs / cefdinir
cefdinir
also known as
BMY-28488 · Cefdinir anhydrous · Cefdinir Capsules · Cefdinir/Omnicef · Cefzon · CI-983 · FK 482 · NSC-758926 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | OMNICEF | — | 1999-07-14 – 1999-11-08 | fda.gov ↗ |
| Approved | US (FDA) | OMNICEF | — | 1997-12-04 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02447224 | Mar → Oct 2015 | appendicitis | Olive View-UCLA Education & Research Institute | Completed | No outcome recorded |
| Phase 15 trials · 4 met primary | ||||||
| Phase 1 | NCT01734759 | Nov 2012 → Jan 2013 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00834535 | Jul → Aug 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00835484 | Jul 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00835549 | Mar 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00834574 | Feb → Mar 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06406114 | May 2025 → Jul 2028 expected | anaphylaxis, drug allergy, drug pseudoallergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03756324 | Dec 2018 → Dec 2020 | mastitis | Beijing University of Chinese Medicine | Unknown | No outcome recorded |
| Phase 2/3 | NCT00645203 | Jul 2002 → Apr 2003 | otitis media | Abbott | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03400735 | Nov 2017 → Apr 2018 | chronic bronchitis, pneumonia | Neutec Ar-Ge San ve Tic A.Ş | Unknown | No outcome recorded |
| Phase 4 | NCT03014687 | Jul 2017 → Jan 2019 overdue | pituitary gland adenoma | St. Joseph's Hospital and Medical Center, Phoenix | Recruiting | No outcome recorded |
| Phase 4 | NCT00234949 | Mar 2005 → ? | — | Abbott | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | NCT01561703 | Mar 2012 → Dec 2013 | streptococcal sore throat | University of Missouri-Columbia | Completed | No outcome recorded |
| — | NCT01000298 | Dec 2009 → May 2011 | kwashiorkor, marasmus | Washington University School of Medicine | Completed | Met primary |
| Comparator or background therapy11 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05702762 Comparator | Oct 2022 → Jun 2023 | cystitis | Mercy Health Ohio | Unknown | No outcome recorded |
| Phase 4 | NCT02891915 Comparator | Dec 2016 → Dec 2019 | pneumonia | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT04664803 Comparator | Aug 2015 → Jun 2019 | sinusitis | Korea United Pharm. Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00147914 Comparator | Feb 2005 → Feb 2007 | sinusitis | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00645112 Comparator | Nov 2003 → Jan 2004 | otitis media | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00645073 Comparator | Nov 2003 → Mar 2004 | sinusitis | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00644943 Comparator | Feb → Apr 2003 | otitis media | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00645125 Comparator | Jan → Feb 2003 | — | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00644774 Comparator | Jan 2003 | — | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT00644891 Comparator | Jan 2003 | — | Abbott | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2007-05-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval and Shipment of Generic Omnicef® Capsules and POS tevapharm.com ↗
the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Applications (ANDA) to market its generic versions of Abbott's antibiotic Omnicef® (Cefdinir) Capsules, 300 mg, and for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2007-05-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval and Shipment of Generic Omnicef® Capsules and POS tevapharm.com ↗ |
| 2005-09-15 | Astellas Pharma Inc | Astellas Filed Lawsuit against Taiyo Yakuhin Co., Ltd. for Infringement of Patent on the Oral Cephalosporin Antibiotic Cefzon Capsule astellas.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cefdinir | “Oral dose regimen for simple urinary tract infection: Including cephalexin, cefdinir, sulfamethoxazole/trimethoprim, and nitrofurantoin at appropriate dose, frequency, and duration” NCT05702762 ↗24“One of seven antibiotics (amoxicillin; amoxicillin/clavulanate potassium; azithromycin; cefaclor; cephalexin; cefdinir; or clindamycin) will be given at standard dosage” NCT01561703 ↗ “cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group)” NCT04664803 ↗ “* Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg” NCT01734759 ↗ “Cefdinir” NCT02099240 ↗ |
| Known as | BMY-28488 | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Known as | Cefdinir anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Known as | Cefdinir Capsules | “Cefdinir Capsules is also named as Cefdinir and produced by Astellas Pharma Inc.” NCT03756324 ↗ |
| Known as | Cefdinir/Omnicef | “Cefdinir/Omnicef” NCT01561703 ↗ |
| Known as | Cefzon | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Known as | CI-983 | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Known as | FK 482 | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Known as | NSC-758926 | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Known as | Omnicef | ChEMBL registry synonym — accepted as the source's own label CHEMBL927 ↗ |
| Modality | Other / unclassified | “oral beta-lactam antibiotic therapy (amoxicillin, amoxicillin-clavulanate, cefdinir)” NCT02891915 ↗ |
| Route | Oral | “cefdinir 300mg per orally twice daily for 10 days” NCT00147914 ↗ |