United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-10-23 article Notices D09002ee1c7fae21c D09002ee1c7fae2c8 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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 Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing. 78 FR 63226 https://www.govinfo.gov/app/details/FR-2013-10-23/2013-24840 2013-24840 fr23oc13-94 4160-01-P Docket No. FDA-2013-N-1137 https://www.govinfo.gov/app/details/FR-2013-10-23/2013-24840 https://www.govinfo.gov/content/pkg/FR-2013-10-23/html/2013-24840.htm https://www.govinfo.gov/content/pkg/FR-2013-10-23/pdf/2013-24840.pdf 2 p. 63226 63227 78 FR 63226 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; Federal Register Vol. 78, Issue NOTICE 2013-24840 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2013-10-23 Docket No. FDA-2013-N-1137 4160-01-P 2013-24840 Notice.

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 Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing.

Effective October 23, 2013. Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301- 796-3601. New Drug Applications: GlaxoSmithKline LLC; BEXXAR; Withdrawal , Vol. 78, no. 205 Office of the Federal Register, National Archives and Records Administration 2013-10-23 continuing daily deposited born digital 424 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-10-23 P0b002ee1864517cd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23oc13 https://www.govinfo.gov/app/details/FR-2013-10-23 https://www.govinfo.gov/content/pkg/FR-2013-10-23/pdf/FR-2013-10-23.pdf https://www.govinfo.gov/content/pkg/FR-2013-10-23/xml/FR-2013-10-23.xml fdlp 62955 63367 DGPO 2013-10-23 2024-06-03 FR-2013-10-23 machine generated eng FR FR-2013-10-23 78 205