• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Ibritumomab Tiuxetan Product Approval Information - Licensing Action

Proper name: Ibritumomab Tiuxetan
Tradename: Zevalin
Manufacturer: IDEC Pharmaceuticals Corp, San Diego, CA, License #1235
Indication for Use: Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. The therapeutic regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan
Approval Date: 2/19/2002
Type of submission: Biologics license application

 


Approval Letter (PDF)

Label (PDF)