botulism immune globulin
Trade name: BabyBIG
BiologicalapprovedOrphan Drug FDA
Approved
Oct 23, 2003
Clinical trial activity
1 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Earliest trial started Jan 1, 1998 (NCT00004401)
Timeline
1980s
- Jan 31, 1989
Orphan Drug Designation
2000s
- Oct 1, 2003
California Department of Public Health — First NDA Organization
- Oct 1, 2003
California Department of Public Health — NDA Organization
- Oct 23, 2003
Earliest FDA Approval
Indications
Approved for
Mechanism of action
- Botulinum neurotoxin type AINHIBITOR
botA inhibitor
Approval history
- approvedOct 23, 2003
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- babybig
- big-iv (botulism immune globulin)
- botulinum antitoxin
- botulism immune globulin
- botulism immune globulin
- botulism immune globulin intravenous (human)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00004401 | N/A | Jan 1, 1998 | California Department of Health Services |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| California Department of Health Services | Government | 1 | 1 | 1 | 1998 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| California Department of Public Health | Government | NDA | Oct 1, 2003 |