{"abstract":"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 Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2013/10/23/2013-24840.html","cfr_references":[],"citation":"78 FR 63226","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective October 23, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1137"],"dockets":[],"document_number":"2013-24840","effective_on":"2013-10-23","end_page":63227,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/10/23/2013-24840.xml","html_url":"https://www.federalregister.gov/documents/2013/10/23/2013-24840/glaxosmithkline-llc-withdrawal-of-approval-of-the-indication-for-treatment-of-patients-with-relapsed","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-24840?publication_date=2013-10-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-10-23/2013-24840/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2138,"last_updated":"2026-07-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-10-23/pdf/2013-24840.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-24840.pdf?1382446278","publication_date":"2013-10-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/10/23/2013-24840.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-11-12T06:03:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63226,"subtype":null,"title":"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","toc_doc":"GlaxoSmithKline LLC; BEXXAR; Withdrawal","toc_subject":"New Drug Applications:","topics":[],"type":"Notice","volume":78}