[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24723-24724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0370]


AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New 
Drug Application for IRESSA

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 IRESSA (gefitinib) Tablets held by 
AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike, P.O. 
Box 8355, Wilmington, DE 19803-8355. AstraZeneca has voluntarily 
requested that approval of this application be withdrawn, thereby 
waiving its opportunity for a hearing.

DATES: Effective April 25, 2012.

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 IRESSA (gefitinib) Tablets on 
May 2, 2003, under the Agency's accelerated approval regulations, 21 
CFR part 314, subpart H. IRESSA is indicated as monotherapy after 
failure of both platinum-based and docetaxel chemotherapies for the 
continued treatment of patients with locally advanced or metastatic 
non-small cell lung cancer who are benefiting or have benefited from 
IRESSA. On August 26, 2010, FDA requested that AstraZeneca voluntarily 
withdraw IRESSA (gefitinib) Tablets from the market, because the 
postmarketing studies required as a condition of approval under subpart 
H failed to verify and confirm clinical benefit. In a letter dated 
February 1, 2011, AstraZeneca requested that FDA withdraw approval of 
NDA 21-399 for IRESSA (gefitinib) Tablets, which AstraZeneca 
characterized as a business decision, effective September 30, 2011. In 
that letter, AstraZeneca waived any opportunity for a hearing otherwise 
provided under Sec. Sec.  314.150 and 314.530. The letter also stated 
that approximately 250 patients then receiving IRESSA treatment through 
the Iressa Access Program would continue treatment under an expanded 
access program, but no new patients would be added to the protocol. In 
FDA's letter of February 4, 2011, responding to AstraZeneca's

[[Page 24724]]

February 1, 2011, letter, the Agency acknowledged AstraZeneca's 
agreement to permit FDA to withdraw approval of IRESSA under Sec.  
314.150(d) and waive its opportunity for a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and 
under authority delegated by the Commissioner to the Director, Center 
for Drug Evaluation and Research, approval of NDA 21-399, 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: April 5, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-9944 Filed 4-24-12; 8:45 am]
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