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Imprese · 23/10/20131 min di lettura
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
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Riepilogo
The 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 LLP, P.O. Box 5089, 1250 South Collegeville Rd., Collegeville, PA 19426 (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →