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U.S. Department of Health and Human Services


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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)