Proper Name: Crotalidae Polyvalent Immune Fab (ovine)
Manufacturer: Protherics Inc.
- Sheep-derived antivenin indicated for the management of adult and pediatric patients with North American crotalid envenomation.
- May 8, 2017 Approval Letter - Crofab
To modify the package insert with new information from pediatric and geriatric subgroup analyses from a retrospective medical chart review.
- February 25, 2017 - Summary Basis for Regulatory Action - CroFab
- Supporting Documents older than three years - CroFab