[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63226-63227]
From the Federal Register Online via the Government Publishing 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approval of this indication be withdrawn and has waived its opportunity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