CROFAB

STN#: 103788
Proper Name: Crotalidae Polyvalent Immune Fab (Ovine)
Tradename: CROFAB
Manufacturer: BTG International, Inc.
Indication:

• Sheep-derived antivenin indicated for the management of adult and pediatric patients with North American crotalid envenomation.

Product Information

• Package Insert - CroFab

Supporting Documents

• August 3, 2018 Approval Letter - CROFAB
• 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