crotalidae polyvalent immune fab (ovine)

Trade name: CroFab

Animal productapprovedOrphan Drug FDA

Approved

Oct 2, 2000

Crotalidae polyvalent immune Fab (ovine), sold under the brandname CroFab, is a snake antivenin, indicated for North American crotalid (rattlesnake, copperhead and cottonmouth/water moccasin) snake envenomation. — Wikipedia

Clinical trial activity

4 trials · 5 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
2
Phase 3
1
Phase 4
2

Earliest trial started Jan 1, 2005 (NCT00868309)

Timeline

1990s

  1. Jan 12, 1994

    Orphan Drug Designation

2000s

  1. Oct 2, 2000

    BTG — Earliest FDA Approval

  2. Oct 2, 2000

    BTG — NDA Secondary Org

  3. Oct 2, 2000

    BTG — NDA Organization

  4. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedOct 2, 2000

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • crofab
  • crofab
  • crofab
  • crotalidae polyvalent immune fab
  • crotalidae polyvalent immune fab, ovine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01864200Phase 4Jul 1, 2013BTG
NCT00636116Phase 3May 1, 2008Instituto Bioclon, National Autonomous University of Mexico, University of Arizona
NCT00303303Phase 4Apr 1, 2005University of Florida
NCT00868309Phase 2Jan 1, 2005Instituto Bioclon, University of Arizona
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Instituto BioclonFor profit2222005
University of ArizonaAcademic/Hospital2022005
BTGFor profit1112013
National Autonomous University of MexicoAcademic/Hospital1012008
University of FloridaAcademic/Hospital1112005
5 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
BTGFor profitNDA2Oct 2, 2000
BTGFor profitNDAOct 2, 2000