[Federal Register Volume 73, Number 17 (Friday, January 25, 2008)]
[Notices]
[Page 4583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007P-0028]


Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for quetiapine fumarate tablets, 150 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Quynh Nguyen, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness 
(Sec.  314.162 (21 CFR 314.162)).
    Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness before an ANDA that refers to that listed drug 
may be approved. FDA may not approve an ANDA that does not refer to a 
listed drug.
    SEROQUEL (quetiapine fumarate) tablets, 150 mg, along with the 25-
mg, 50-mg, 100-mg, 200-mg, 300-mg, and 400-mg strengths, are the 
subject of approved NDA 20-639 held by AstraZeneca Pharmaceuticals LP 
(AstraZeneca). SEROQUEL (quetiapine fumarate) tablets are in a class of 
medications called atypical antipsychotics. Antipsychotic medicines are 
used to treat symptoms of schizophrenia. SEROQUEL (quetiapine fumarate) 
tablets may be used alone or with lithium or divalproex to treat acute 
manic episodes in adults who have a condition called Bipolar I 
Disorder.
    AstraZeneca obtained approval to market the 150-mg strength of 
SEROQUEL (quetiapine fumarate) tablets on December 20, 1998. Lachman 
Consultant Services, Inc., submitted a citizen petition dated January 
16, 2007, (Docket No. 2007P-0028/CP1), under 21 CFR 10.30, requesting 
that the agency determine, as described in Sec.  314.161, whether 
SEROQUEL (quetiapine fumarate) tablets, 150 mg, were withdrawn from 
sale for reasons of safety or effectiveness. After considering the 
citizen petition (including the comment(s) submitted) and reviewing 
agency records, the agency has determined that AstraZeneca's SEROQUEL 
(quetiapine fumarate) tablets, 150 mg, were not withdrawn from sale for 
reasons of safety or effectiveness. AstraZeneca has never marketed 
SEROQUEL (quetiapine fumarate) tablets, 150 mg, in the United States, 
although the 150-mg tablets are marketed in some countries outside the 
United States. In previous instances (see, e.g., 67 FR 79640, December 
30, 2002 (addressing a relisting request for Diazepam Autoinjector)), 
the agency has determined that, for purposes of Sec. Sec.  314.161 and 
314.162, never marketing an approved drug product in the United States 
is equivalent to withdrawing the drug from sale.
    The petitioner identified no data or other information suggesting 
that SEROQUEL (quetiapine fumarate) tablets, 150 mg, were withdrawn 
from sale as a result of safety or effectiveness concerns. AstraZeneca 
has marketed other strengths of SEROQUEL (quetiapine fumarate) tablets: 
25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg. The agency has 
reviewed its files for records concerning the withdrawal of SEROQUEL 
(quetiapine fumarate) tablets, 150 mg. There is no indication that 
AstraZeneca decided not to market SEROQUEL (quetiapine fumarate) 
tablets, 150 mg, in the United States for safety or effectiveness 
reasons. FDA has independently evaluated relevant literature and data 
for reports of adverse events and has found no information that would 
indicate that SEROQUEL (quetiapine fumarate) tablets, 150 mg, were 
withdrawn for reasons of safety or effectiveness.
    FDA determines that for the reasons outlined in this document, 
AstraZeneca's SEROQUEL (quetiapine fumarate) tablets, 150 mg, were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list SEROQUEL (quetiapine 
fumarate) tablets, 150 mg, in the ``Discontinued Drug Product List'' 
section of the Orange Book. The ``Discontinued Drug Product List'' 
delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs that refer to SEROQUEL (quetiapine fumarate) 
tablets, 150 mg, may be approved by the agency as long as they meet all 
relevant legal and regulatory requirements for the approval of ANDAs. 
If FDA determines that labeling for Seroquel (quetiapine fumarate) 
tablets, 150 mg, should be revised to meet current standards, the 
agency will advise ANDA applicants to submit such labeling.

    Dated: January 16, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1298 Filed 1-24-08; 8:45 am]
BILLING CODE 4160-01-S