botulism antitoxin bivalent (equine) types a and b
Biologicalapproved
Approved
Feb 24, 2000
Clinical trial activity
1 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
0
Phase 3
0
Phase 4
0
Earliest trial started Feb 1, 2008 (NCT00636519)
Timeline
2000s
- Feb 24, 2000
Sanofi-Aventis — Earliest FDA Approval
- Feb 24, 2000
Sanofi-Aventis — NDA Secondary Org
- Feb 24, 2000
Sanofi-Aventis — NDA Organization
- Jan 1, 2008
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- Botulinum neurotoxin type AImmunity, passive
botA immunity, passive
Approval history
- approvedFeb 24, 2000
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- botulism antitoxin bivalent (equine) types a and b
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00636519 | Phase 1 | Feb 1, 2008 | Cangene, Department of Health and Human Services, Loma Linda University, R. Richard Sloop, M. D. |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cangene | For profit | 1 | 1 | 1 | 2008 |
| Department of Health and Human Services | Government | 1 | 0 | 1 | 2008 |
| Loma Linda University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| R. Richard Sloop, M. D. | Academic/Hospital | 1 | 0 | 1 | 2008 |
4 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi-Aventis | For profit | NDA2 | Feb 24, 2000 |
| Sanofi-Aventis | For profit | NDA | Feb 24, 2000 |