[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]
[Page 4583]
[DOCID:fr25ja08-83]

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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Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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,<PHONE_NUMBER>.

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drug was withdrawn from sale for reasons of safety or effectiveness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


[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Page 75351]
[FR Doc No: 2023-24174]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98809; File No. SR-CboeBZX-2023-068]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Withdrawal of Proposed Rule Change To Amend Its Fee Schedule Related to
Physical Port Fees

October 27, 2023.
    On September 1, 2023, Cboe BZX Exchange, Inc. (``Exchange'') filed
with the Securities and Exchange Commission (``Commission''), pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend certain connectivity and port fees.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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    The proposed rule change was immediately effective upon filing with
the Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ The
proposed rule change was published for comment in the Federal Register
on September 20, 2023.\4\ On September 29, 2023, pursuant to Section
19(b)(3)(C) of the Act,\5\ the Commission: (1) temporarily suspended
the proposed rule change; and (2) instituted proceedings under Section
19(b)(2)(B) of the Act \6\ to determine whether to approve or
disapprove the proposed rule change.\7\ On October 25, 2023, the
Exchange withdrew the proposed rule change (SR-CboeBZX-2023-068).
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    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release No. 98389 (September 14,
2023), 88 FR 64957.
    \5\ 15 U.S.C. 78s(b)(3)(C).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 98650, 88 FR 68787
(October 4, 2023).
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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-24174 Filed 11-1-23; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

Electronic cigarettes and similar devices are significantly safer than the alternative (combustable) tobacco cigarettes. However, many e-cig users use neither nicotine nor tobacco products in the "e-liquid" used in these devices, so I feel that throwing the blanket of "tobacco product" over the entire e-cig industry is harmful and inaccurate. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.