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(PDF - 33KB)
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(PDF - 62KB) October 2, 2000 Approval Letter - CroFab
Indication: Treatment of minimal and moderate North American Crotalidae envenomation.
Summary Basis for Approval - CroFab(PDF - 107KB)