Document ID: FDA-2011-N-0828-0001
Agency: fda
Document Type: Notice
Title: Withdrawals of Approval of New Drug Applications: MYLOTARG, Wyeth Pharmaceuticals, Inc.
Posted Date: 2011-11-28T05:00Z

[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Page 72955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30473]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0828]

Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug 
Application for MYLOTARG

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) 
for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola 
Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has 
voluntarily requested that approval of this application be withdrawn, 
thereby waiving its opportunity for a hearing.

DATES: Effective November 28, 2011.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, (301) 796-3601.

SUPPLEMENTARY INFORMATION: FDA approved MYLOTARG (gemtuzumab 
ozogamicin) for Injection on May 17, 2000, under the Agency's 
accelerated approval regulations, 21 CFR part 314, subpart H. MYLOTARG 
was indicated for the treatment of patients with CD33-positive acute 
myeloid leukemia in first relapse who were 60 years of age or older and 
who were not considered candidates for other cytotoxic chemotherapy. On 
May 21, 2010, FDA requested that Wyeth voluntarily withdraw MYLOTARG 
from the market, after results of a required postapproval clinical 
trial failed to verify clinical benefit to patients and raised new 
concerns about the drug's safety. In a letter dated October 25, 2010, 
Wyeth requested that FDA withdraw approval of NDA 21-174, MYLOTARG 
(gemtuzumab ozogamicin) for Injection, under Sec.  314.150(d) (21 CFR 
314.150(d)). In that letter, Wyeth also waived its opportunity for a 
hearing, provided under 21 CFR 314.150 and 314.530. In FDA's 
acknowledgment letter of November 2, 2010, the Agency stated that a 
large prospective trial that tested the addition of MYLOTARG to first-
line chemotherapy for patients with newly diagnosed acute myelogenous 
leukemia failed to verify clinical benefit of MYLOTARG and raised 
safety concerns. FDA also acknowledged that Wyeth waived its 
opportunity for a hearing.
    Therefore, under sections 505(e) and 506(b)(3) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e) and 356(b)(3)) and 
Sec.  314.150(d), and under authority delegated by the Commissioner to 
the Director, Center for Drug Evaluation and Research, approval of NDA 
21-174, and all amendments and supplements thereto, is withdrawn (see 
DATES). Distribution of this product in interstate commerce without an 
approved application is illegal and subject to regulatory action (see 
sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 
331(d))).

    Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30473 Filed 11-25-11; 8:45 am]
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