Trimethobenzamide Hydrochloride Suppositories; Withdrawal of Approval, 17556-17558 [E7-6593]
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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 3, 2007.
Diane Allen,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–6591 Filed 4–6–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry; The Board of
Scientific Counselors (BSC), Centers
for Disease Control and Prevention
(CDC), National Center for
Environmental Health (NCEH)/Agency
for Toxic Substances and Disease
Registry (ATSDR): Meeting
sroberts on PROD1PC70 with NOTICES
In accordance with section 10(a)(2) of the
Federal Advisory Committee Act (Pub. L. 92–
463), CDC and ATSDR announce the
following meeting of the aforementioned
committee:
Times and Dates: 8 a.m.–4:45 p.m.,
May 17, 2007. 8 a.m.–12 p.m., May 18,
2007.
Place: 1825 Century Boulevard,
Atlanta, Georgia 30345.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 75
people.
Purpose: The Secretary, Department
of Health and Human Services (HHS),
and by delegation, the Director, CDC,
are authorized under Section 301 (42
U.S.C. 241) and Section 311 (42 U.S.C.
243) of the Public Health Service Act, as
amended, to: (1) Conduct, encourage,
cooperate with, and assist other
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institutions, and scientists in the
conduct of research, investigations,
experiments, demonstrations, and
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promotion of health and well being; and
(3) train state and local personnel in
health work. The BSC, NCEH/ATSDR
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Secretary, HHS; the Director, CDC, and
Administrator, ATSDR; and the
Director, NCEH/ATSDR, regarding
program goals, objectives, strategies, and
priorities in fulfillment of the agency’s
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mission to protect and promote people’s
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in ensuring scientific quality,
timeliness, utility, and dissemination of
results. The board also provides
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Matters To Be Discussed: An update
on NCEH/ATSDR’s Office of the
Director; an update on Science and
Public Health and Reports; an update on
the Health Department Subcommittee,
the Community and Tribal
Subcommittee, and the Program Peer
Review Subcommittee (PPRS) Reports
and Discussion; a presentation on CDC’s
Web site redesign and the NCEH/
ATSDR Web site; an update on Climate
Change Initiative; a presentation on the
Office of Tribal Affairs’ Expert Panel
Report; an update on issues from the
Board; a discussion on the Office of
Management and Budget Performance
Assessment and Review Techniques
goals and objectives; an update on the
National Exposure Report; an update on
Preparedness and Emergency Response
priorities and portfolio; and a
discussion on BSC—PPRS Draft Peer
Review Report on ATSDR Site-Specific
Activities.
Agenda items are tentative and
subject to change.
FOR FURTHER INFORMATION CONTACT:
Sandra Malcom, Committee
Management Specialist, NCEH/ATSDR,
1600 Clifton Road, Mail Stop E–28,
Atlanta, Georgia 30303; telephone 404/
498–0003, fax 404/498–0622; E-mail:
smalcom@cdc.gov. The deadline for
notification of attendance is May 4,
2007.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
NCEH/ATSDR.
Dated: April 2, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–6585 Filed 4–6–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1978N–0224 (formerly Docket
No. 78N–0224); DESI 11853]
Trimethobenzamide Hydrochloride
Suppositories; Withdrawal of Approval
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
resolution of issues concerning
trimethobenzamide hydrochloride
suppositories. This notice announces
the withdrawal of approval of the new
drug application (NDA) for Tigan
(trimethobenzamide hydrochloride)
Suppositories. The notice also declares
that the marketing of unapproved
trimethobenzamide hydrochloride
suppository products is unlawful and
subject to FDA regulatory action. FDA is
taking these actions because
trimethobenzamide hydrochloride
suppositories lack substantial evidence
of effectiveness.
ADDRESSES: Requests for an opinion on
the applicability of this notice to a
specific trimethobenzamide
hydrochloride suppository product
should be identified with Docket No.
1978N–0224 and reference number DESI
11853 and directed to the Office of
Compliance, Division of New Drugs and
Labeling Compliance (HFD–310), New
Drugs and Labeling Team, Center for
Drug Evaluation and Research, Food
and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852.
DATE: Effective May 9, 2007.
FOR FURTHER INFORMATION CONTACT:
Brian L. Pendleton, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
I. Background
As part of its Drug Efficacy Study
Implementation (DESI) program, in a
notice published in the Federal Register
on February 24, 1971 (36 FR 3435) (the
1971 notice), FDA announced the
following conclusions regarding certain
drug products that contain
trimethobenzamide hydrochloride: (1)
The products were probably effective for
nausea and vomiting due to radiation
therapy or travel sickness and for emesis
associated with operative procedures,
labyrinthitis, or Meniere’s syndrome; (2)
they were lacking substantial evidence
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09APN1
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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices
of effectiveness for the treatment of
nausea and vomiting due to infections,
underlying disease processes, or drug
administration; and (3) they were
possibly effective for all other labeled
indications. The 1971 notice listed three
trimethobenzamide hydrochloride
products: Tigan Solution for Injection
(NDA 11–853), Tigan Capsules (NDA
11–854), and Tigan Suppositories (NDA
11–855). Roche Laboratories held the
NDAs for these three products.
On January 9, 1979, we published a
notice in the Federal Register (44 FR
2021) (the 1979 suppository notice)
announcing that we were reclassifying
trimethobenzamide hydrochloride
suppositories to lacking substantial
evidence of effectiveness and proposing
to withdraw approval of the NDAs for
trimethobenzamide hydrochloride
suppositories. The 1979 suppository
notice stated that NDA 17–529 for Tigan
Suppositories, held by Beecham
Laboratories (Beecham), had not been
included in the 1971 notice, but was
affected by the new notice. (In the same
issue of the January 9, 1979, Federal
Register (44 FR 2017) (the 1979
injection and capsule notice), we
published a notice announcing that we
were reclassifying trimethobenzamide
hydrochloride injection and capsules to
effective for certain indications and to
lacking substantial evidence of
effectiveness for their other (previously
designated) less-than-effective
indications. On December 24, 2002, we
published the final evaluation for
trimethobenzamide hydrochloride
injection and capsules (67 FR 78476).)
In the 1979 suppository notice, we
gave notice of an opportunity for a
hearing to the holders of the NDAs for
trimethobenzamide hydrochloride
suppositories, and to all other interested
persons, stating that we proposed to
issue an order under section 505(e) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355(e))
withdrawing approval of the NDAs and
all amendments and supplements
thereto (44 FR 2021 at 2021 to 2022). We
stated that the notice of an opportunity
for a hearing encompassed all issues
relating to the legal status of the drug
products subject to the notice, including
identical, related, or similar drug
products as defined in § 310.6 (21 CFR
310.6) of our regulations. In accordance
with section 505 of the act and parts 310
and 314 (21 CFR parts 310 and 314), we
gave the holders of the NDAs and all
other persons who manufacture or
distribute a drug product that is
identical, related, or similar to a drug
product named in the notice an
opportunity for a hearing to show why
approval of the NDAs involved should
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18:21 Apr 06, 2007
Jkt 211001
not be withdrawn, and an opportunity
to raise, for administrative
determination, all issues relating to the
legal status of a named drug product
and all identical, related, or similar drug
products (44 FR 2021 at 2022).
The 1979 suppository notice stated
that the failure of an applicant or any
other person subject to the notice to file
a timely written appearance and request
for a hearing, as required by § 314.200,
constituted an election by the person
not to make use of the opportunity for
a hearing and a waiver of any
contentions concerning the legal status
of any drug product subject to the
notice. The notice further stated that
any such drug product could not
thereafter lawfully be marketed, and we
would initiate appropriate regulatory
action to remove such drug products
from the market (44 FR 2021 at 2022).
In a letter dated January 30, 1979,
Beecham requested a hearing on the
proposed withdrawal of NDA 17–529
for Tigan Suppositories. In a letter dated
March 5, 1979, Beecham submitted data
in support of its request for a hearing.
Beecham was the only party to request
a hearing. On April 13, 1979, we
published a notice in the Federal
Register announcing that we were
withdrawing the approval of NDA 11–
8550 (the only other NDA named in the
1979 suppository notice), effective April
23, 1979 (44 FR 22199).
On November 12, 1999, King
Pharmaceuticals, Inc., 501 Fifth St.,
Bristol, TN 37620 (King), purchased
from Roberts Pharmaceutical Corp. the
NDAs for the Tigan products previously
held by Beecham: NDA 17–529
(suppositories), NDA 17–530 (injection),
and NDA 17–531 (capsules). We
subsequently initiated discussions with
King on bringing the Tigan products
into compliance with the 1979 notices
on trimethobenzamide hydrochloride
drugs.
In an agreement that became effective
on August 16, 2001 (the Agreement),
FDA and King agreed to take several
actions to resolve the matter of the
compliance of Tigan products with the
1979 notices. Among other things, King
agreed to withdraw the request for a
hearing (originally submitted by
Beecham) on matters related to NDAs
17–529 (Tigan Suppositories), 17–530
(Tigan Injection), and 17–531 (Tigan
Capsules), and all amendments and
supplements thereto, within 10 days of
the effective date of the Agreement. In
a letter dated August 24, 2001, King
withdrew its request for a hearing on
these matters in accordance with the
Agreement. The issues relating to Tigan
Capsules and Injection were resolved in
2001 and 2002, and on December 24,
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17557
2002, we published a notice in the
Federal Register announcing our final
evaluation of these products (67 FR
78476).
II. Resolution of Issues Concerning
Tigan Suppositories
King notified us in a letter dated
March 21, 2005, that it had decided not
to pursue additional studies for Tigan
Suppositories. In a letter dated August
19, 2005, we asked King, in accordance
with the Agreement, to request the
withdrawal of NDA 17–529 for Tigan
Suppositories. In a letter dated
September 6, 2005, King requested that
we withdraw NDA 17–529.
As stated in section I of this
document, King has withdrawn its
request for a hearing on matters related
to NDA 17–529. No party other than
Beecham (a previous holder of NDA 17–
529) submitted a request for a hearing in
response to the 1979 suppository notice.
Therefore, all other parties waived any
possible contentions regarding the legal
status of their trimethobenzamide
hydrochloride suppository products.
III. Withdrawal of Approval of NDA
17–529 for Tigan Suppositories
As a result of the events described in
section II of this document, we have
concluded that Tigan Suppositories
have not been shown to be effective.
Therefore, we are withdrawing approval
of the NDA for this product.
Under § 310.6, this notice applies to
any drug product that is identical,
related, or similar to Tigan
Suppositories and is not the subject of
an approved NDA. Any person who
wishes to determine whether a specific
product is covered by this notice should
write to the Division of New Drugs and
Labeling Compliance (see ADDRESSES).
The Director of the Center for Drug
Evaluation and Research, under section
505(e) of the act and under the authority
delegated to him, finds that, on the basis
of the information in this docket on
Tigan Suppositories (NDA 17–529),
evaluated together with the evidence
available to FDA when the application
for this product was approved, there is
a lack of substantial evidence that this
product has the effect it purports or is
represented to have under the
conditions of use prescribed,
recommended, or suggested in its
labeling.
Therefore, based on the foregoing
finding, the approval of NDA 17–529,
including all amendments and
supplements thereto, is withdrawn
effective May 9, 2007. Shipment in
interstate commerce of Tigan
Suppositories or any identical, related,
or similar trimethobenzamide
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17558
Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices
hydrochloride suppository product that
is not the subject of an approved NDA
will then be unlawful.
We note that under enforcement
policies regarding drugs marketed
without required applications described
in the agency’s guidance entitled
Marketed Unapproved Drugs—
Compliance Policy Guide, it is a high
priority for the agency to take
enforcement action against those
unapproved drug products that lack
evidence of effectiveness. Firms should
be aware that we intend to take
enforcement action without further
notice against any firm that
manufactures or ships in interstate
commerce any unapproved product
covered by this notice after May 9, 2007.
Firms that discontinue or have already
discontinued manufacturing products
covered by this notice may want to
notify us that they are no longer
manufacturing those products. A firm
that wishes to notify us of product
discontinuation should send a letter,
signed by the firm’s chief executive
officer, fully identifying the
discontinued product, including its
National Drug Code (NDC) number. The
firm should send the letter to the
Division of New Drugs and Labeling
Compliance, New Drugs and Labeling
Team (see ADDRESSES). Firms should
also update the listing of their products
under section 510(j) of the act (21 U.S.C.
360(j)) to reflect discontinuation of
unapproved or otherwise discontinued
products. We plan to rely on our
existing records, the results of a
subsequent inspection, or other
available information when we evaluate
whether to take enforcement action.
Dated: March 14, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–6593 Filed 4–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
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18:21 Apr 06, 2007
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Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 26, 2007, from 2 p.m. to
6 p.m. and on April 27, 2007, from 8
a.m. to 3:30 p.m.
Location: Hilton Hotel, Washington,
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike (HFM–71),
Rockville, MD 20852, 301–827–0314, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On April 26, 2007, the
committee will hear an update on a
summary of August 30 and 31, 2006,
meeting of the Department of Health
and Human Services Advisory
Committee on Blood Safety and
Availability. The committee will then
discuss issues related to implementation
of blood donor screening for infection
with Trypanosoma cruzi and issues
related to transmissibility of
Trypanosoma cruzi in donors of human
cells, tissue, and cellular and tissuebased products. On April 27, 2007, the
committee will hear updates on
summary of December 15, 2006, meeting
of the Transmissible Spongiform
Encephelopathies Advisory Committee,
FDA’s risk communication on plasmaderived Factor VIII and Factor XI, and
summary of September 25 and 26, 2006,
FDA Workshop on Molecular Methods
in Immunohematology. The committee
will then discuss transfusion related
acute lung injury, and discuss issues
related to implementation of blood
donor screening for infection with West
Nile Virus.
FDA intends to make background
material available to the public no later
than 1 business day before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
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Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 18, 2007. Oral
presentations from the public will be
scheduled between approximately 4:30
p.m. and 5 p.m. on April 26, 2007, and
between approximately 10:45 a.m. and
11:15 a.m. on April 27, 2007. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 10,
2007. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 11, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Pearline K. Muckelvene at least
7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–6594 Filed 4–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
General Hospital and Personal Use
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Notices]
[Pages 17556-17558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1978N-0224 (formerly Docket No. 78N-0224); DESI 11853]
Trimethobenzamide Hydrochloride Suppositories; Withdrawal of
Approval
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
resolution of issues concerning trimethobenzamide hydrochloride
suppositories. This notice announces the withdrawal of approval of the
new drug application (NDA) for Tigan (trimethobenzamide hydrochloride)
Suppositories. The notice also declares that the marketing of
unapproved trimethobenzamide hydrochloride suppository products is
unlawful and subject to FDA regulatory action. FDA is taking these
actions because trimethobenzamide hydrochloride suppositories lack
substantial evidence of effectiveness.
ADDRESSES: Requests for an opinion on the applicability of this notice
to a specific trimethobenzamide hydrochloride suppository product
should be identified with Docket No. 1978N-0224 and reference number
DESI 11853 and directed to the Office of Compliance, Division of New
Drugs and Labeling Compliance (HFD-310), New Drugs and Labeling Team,
Center for Drug Evaluation and Research, Food and Drug Administration,
11919 Rockville Pike, Rockville, MD 20852.
DATE: Effective May 9, 2007.
FOR FURTHER INFORMATION CONTACT: Brian L. Pendleton, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
As part of its Drug Efficacy Study Implementation (DESI) program,
in a notice published in the Federal Register on February 24, 1971 (36
FR 3435) (the 1971 notice), FDA announced the following conclusions
regarding certain drug products that contain trimethobenzamide
hydrochloride: (1) The products were probably effective for nausea and
vomiting due to radiation therapy or travel sickness and for emesis
associated with operative procedures, labyrinthitis, or Meniere's
syndrome; (2) they were lacking substantial evidence
[[Page 17557]]
of effectiveness for the treatment of nausea and vomiting due to
infections, underlying disease processes, or drug administration; and
(3) they were possibly effective for all other labeled indications. The
1971 notice listed three trimethobenzamide hydrochloride products:
Tigan Solution for Injection (NDA 11-853), Tigan Capsules (NDA 11-854),
and Tigan Suppositories (NDA 11-855). Roche Laboratories held the NDAs
for these three products.
On January 9, 1979, we published a notice in the Federal Register
(44 FR 2021) (the 1979 suppository notice) announcing that we were
reclassifying trimethobenzamide hydrochloride suppositories to lacking
substantial evidence of effectiveness and proposing to withdraw
approval of the NDAs for trimethobenzamide hydrochloride suppositories.
The 1979 suppository notice stated that NDA 17-529 for Tigan
Suppositories, held by Beecham Laboratories (Beecham), had not been
included in the 1971 notice, but was affected by the new notice. (In
the same issue of the January 9, 1979, Federal Register (44 FR 2017)
(the 1979 injection and capsule notice), we published a notice
announcing that we were reclassifying trimethobenzamide hydrochloride
injection and capsules to effective for certain indications and to
lacking substantial evidence of effectiveness for their other
(previously designated) less-than-effective indications. On December
24, 2002, we published the final evaluation for trimethobenzamide
hydrochloride injection and capsules (67 FR 78476).)
In the 1979 suppository notice, we gave notice of an opportunity
for a hearing to the holders of the NDAs for trimethobenzamide
hydrochloride suppositories, and to all other interested persons,
stating that we proposed to issue an order under section 505(e) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e))
withdrawing approval of the NDAs and all amendments and supplements
thereto (44 FR 2021 at 2021 to 2022). We stated that the notice of an
opportunity for a hearing encompassed all issues relating to the legal
status of the drug products subject to the notice, including identical,
related, or similar drug products as defined in Sec. 310.6 (21 CFR
310.6) of our regulations. In accordance with section 505 of the act
and parts 310 and 314 (21 CFR parts 310 and 314), we gave the holders
of the NDAs and all other persons who manufacture or distribute a drug
product that is identical, related, or similar to a drug product named
in the notice an opportunity for a hearing to show why approval of the
NDAs involved should not be withdrawn, and an opportunity to raise, for
administrative determination, all issues relating to the legal status
of a named drug product and all identical, related, or similar drug
products (44 FR 2021 at 2022).
The 1979 suppository notice stated that the failure of an applicant
or any other person subject to the notice to file a timely written
appearance and request for a hearing, as required by Sec. 314.200,
constituted an election by the person not to make use of the
opportunity for a hearing and a waiver of any contentions concerning
the legal status of any drug product subject to the notice. The notice
further stated that any such drug product could not thereafter lawfully
be marketed, and we would initiate appropriate regulatory action to
remove such drug products from the market (44 FR 2021 at 2022).
In a letter dated January 30, 1979, Beecham requested a hearing on
the proposed withdrawal of NDA 17-529 for Tigan Suppositories. In a
letter dated March 5, 1979, Beecham submitted data in support of its
request for a hearing. Beecham was the only party to request a hearing.
On April 13, 1979, we published a notice in the Federal Register
announcing that we were withdrawing the approval of NDA 11-8550 (the
only other NDA named in the 1979 suppository notice), effective April
23, 1979 (44 FR 22199).
On November 12, 1999, King Pharmaceuticals, Inc., 501 Fifth St.,
Bristol, TN 37620 (King), purchased from Roberts Pharmaceutical Corp.
the NDAs for the Tigan products previously held by Beecham: NDA 17-529
(suppositories), NDA 17-530 (injection), and NDA 17-531 (capsules). We
subsequently initiated discussions with King on bringing the Tigan
products into compliance with the 1979 notices on trimethobenzamide
hydrochloride drugs.
In an agreement that became effective on August 16, 2001 (the
Agreement), FDA and King agreed to take several actions to resolve the
matter of the compliance of Tigan products with the 1979 notices. Among
other things, King agreed to withdraw the request for a hearing
(originally submitted by Beecham) on matters related to NDAs 17-529
(Tigan Suppositories), 17-530 (Tigan Injection), and 17-531 (Tigan
Capsules), and all amendments and supplements thereto, within 10 days
of the effective date of the Agreement. In a letter dated August 24,
2001, King withdrew its request for a hearing on these matters in
accordance with the Agreement. The issues relating to Tigan Capsules
and Injection were resolved in 2001 and 2002, and on December 24, 2002,
we published a notice in the Federal Register announcing our final
evaluation of these products (67 FR 78476).
II. Resolution of Issues Concerning Tigan Suppositories
King notified us in a letter dated March 21, 2005, that it had
decided not to pursue additional studies for Tigan Suppositories. In a
letter dated August 19, 2005, we asked King, in accordance with the
Agreement, to request the withdrawal of NDA 17-529 for Tigan
Suppositories. In a letter dated September 6, 2005, King requested that
we withdraw NDA 17-529.
As stated in section I of this document, King has withdrawn its
request for a hearing on matters related to NDA 17-529. No party other
than Beecham (a previous holder of NDA 17-529) submitted a request for
a hearing in response to the 1979 suppository notice. Therefore, all
other parties waived any possible contentions regarding the legal
status of their trimethobenzamide hydrochloride suppository products.
III. Withdrawal of Approval of NDA 17-529 for Tigan Suppositories
As a result of the events described in section II of this document,
we have concluded that Tigan Suppositories have not been shown to be
effective. Therefore, we are withdrawing approval of the NDA for this
product.
Under Sec. 310.6, this notice applies to any drug product that is
identical, related, or similar to Tigan Suppositories and is not the
subject of an approved NDA. Any person who wishes to determine whether
a specific product is covered by this notice should write to the
Division of New Drugs and Labeling Compliance (see ADDRESSES).
The Director of the Center for Drug Evaluation and Research, under
section 505(e) of the act and under the authority delegated to him,
finds that, on the basis of the information in this docket on Tigan
Suppositories (NDA 17-529), evaluated together with the evidence
available to FDA when the application for this product was approved,
there is a lack of substantial evidence that this product has the
effect it purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in its labeling.
Therefore, based on the foregoing finding, the approval of NDA 17-
529, including all amendments and supplements thereto, is withdrawn
effective May 9, 2007. Shipment in interstate commerce of Tigan
Suppositories or any identical, related, or similar trimethobenzamide
[[Page 17558]]
hydrochloride suppository product that is not the subject of an
approved NDA will then be unlawful.
We note that under enforcement policies regarding drugs marketed
without required applications described in the agency's guidance
entitled Marketed Unapproved Drugs--Compliance Policy Guide, it is a
high priority for the agency to take enforcement action against those
unapproved drug products that lack evidence of effectiveness. Firms
should be aware that we intend to take enforcement action without
further notice against any firm that manufactures or ships in
interstate commerce any unapproved product covered by this notice after
May 9, 2007. Firms that discontinue or have already discontinued
manufacturing products covered by this notice may want to notify us
that they are no longer manufacturing those products. A firm that
wishes to notify us of product discontinuation should send a letter,
signed by the firm's chief executive officer, fully identifying the
discontinued product, including its National Drug Code (NDC) number.
The firm should send the letter to the Division of New Drugs and
Labeling Compliance, New Drugs and Labeling Team (see ADDRESSES). Firms
should also update the listing of their products under section 510(j)
of the act (21 U.S.C. 360(j)) to reflect discontinuation of unapproved
or otherwise discontinued products. We plan to rely on our existing
records, the results of a subsequent inspection, or other available
information when we evaluate whether to take enforcement action.
Dated: March 14, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-6593 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S
