Document ID: FDA-2013-N-1137-0001
Agency: fda
Document Type: Notice
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
Posted Date: 2013-10-23T04:00Z

[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63226-63227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24840]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1137]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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approval of this indication be withdrawn and has waived its opportunity 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.

DATES: Effective October 23, 2013.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: FDA approved BEXXAR on June 27, 2003, for 
the treatment of patients with CD20 positive, relapsed or refractory, 
low-grade, follicular, or transformed non-Hodgkin's lymphoma who have 
progressed during or after rituximab therapy. On December 22, 2004, FDA 
approved a new indication to include patients who have not received 
prior rituximab (the rituximab-na[iuml]ve indication) under the 
Agency's accelerated approval regulations for biological products, 21 
CFR part 601, subpart E.
    On December 13, 2011, FDA requested that Glaxo voluntarily withdraw 
the rituximab-na[iuml]ve indication for BEXXAR (tositumomab and iodine 
I 131 tositumomab) Injection because the postmarketing study intended 
to verify clinical benefit and required as a condition of approval 
under part 601, subpart E was not completed. Withdrawal of approval of 
the rituximab-na[iuml]ve indication does not otherwise affect the 
approved indication for BEXXAR.

[[Page 63227]]

    On April 23, 2012, Glaxo submitted a prior approval labeling 
supplement requesting removal of the rituximab-na[iuml]ve indication 
for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection from 
the package insert. In the cover letter accompanying the supplement, 
Glaxo requested that FDA withdraw the rituximab-na[iuml]ve indication 
for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection from 
the market and waived its opportunity for a hearing. In a letter dated 
May 11, 2012, FDA acknowledged receipt of the prior approval labeling 
supplement and Glaxo's request to withdraw the rituximab-na[iuml]ve 
indication for BEXXAR (tositumomab and iodine I 131 tositumomab) 
Injection. Glaxo's labeling supplement was approved by FDA in a letter 
dated August 15, 2012. Therefore, under section 506 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 356) and Sec.  
601.43, and under authority delegated by the Commissioner to the 
Director, Center for Drug Evaluation and Research, approval of the 
rituximab-na[iuml]ve indication for BEXXAR (tositumomab and iodine I 
131 tositumomab) Injection is withdrawn as of October 23, 2013.

    Dated: October 18, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-24840 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P