GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With Relapsed or Refractory, Low Grade, Follicular, or Transformed CD20 Positive Non-Hodgkin’s Lymphoma Who Have Not Received Prior Rituximab; BEXXAR

The US Food and Drug Administration (FDA) is withdrawing approval of the indication for treatment of patients with relapsed or refractory, low grade, follicular, or transformed CD20 positive non-Hodgkin’s lymphoma who have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held by GlaxoSmithKline (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing (US FDA, OCT 23, 2013, View Source).

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