Determination That ENDURON (methyclothiazide) Tablets and Six Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 59403-59404 [2012-23779]
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Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Notices
• California will increase the number
of participants attending the Border
Health Research Forum and will host a
stakeholders meeting in support of the
Prevention and Health Promotion
among Vulnerable Populations on the
U.S.-Mexico Border Initiative.
• Texas will increase the number of
participants attending the Border
Binational Obesity Prevention Summit,
to share knowledge and best practices
regarding a critical problem affecting
border populations.
• New Mexico will plan, coordinate,
and execute Phase IV of the Healthy
Border 2010/2020 Strategic Plan, and
will increase the number of regional
activities of the Prevention and Health
Promotion among Vulnerable
Populations on the U.S.-Mexico Border
Initiative, to improve health outcomes
of vulnerable populations living on the
U.S.-Mexico Border.
II. Award Information
The administrative and funding
instrument to be used for this program
will be cooperative agreements in which
substantial OGA/HHS scientific and/or
programmatic involvement is
anticipated during the performance of
these projects. Under the cooperative
agreements, OGA/HHS will support
and/or stimulate awardees activities by
working with them in a non-directive
partnership role. Awardees will also be
expected to work directly with and in
support of the U.S.-Mexico Border
Health Commission and its stated goals
and initiatives as outlined in the
submitted work plan.
Approximately $150,000.00
($37,500.00 to each State) in fiscal year
(FY) 2012 funds are available as
supplemental funding to the already
existing agreements. The anticipated
start date is September 30, 2012 through
August 31, 2013. There will only be four
awards made from this announcement.
erowe on DSK2VPTVN1PROD with
III. Justification for the Exception to
Competition
15:00 Sep 26, 2012
Jkt 226001
IV. Agency Contacts
For programmatic requirements,
please contact: Craig Shapiro MD, Office
of Global Affairs, DHHS, Mary E.
Switzer Building, 330 C Street, SW.,
Washington, DC 20201, Phone: (202)
260–0399.
For administrative requirements
please contact: Alice Bettencourt,
Director, Office of Grants Management,
Office of the Assistant Secretary for
Health, 1101 Wotton Parkway, Suite
550, Rockville, MD 20852, Telephone:
(240) 453–8822.
Dated: September 20, 2012.
Jimmy Kolker,
Principal Deputy Director.
[FR Doc. 2012–23722 Filed 9–26–12; 8:45 am]
BILLING CODE 4150–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0190]
Determination That ENDURON
(methyclothiazide) Tablets and Six
Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the seven drug products listed in
this document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
The supplemental funding is for
ongoing, cooperative agreements already
awarded to the border health offices in
the States of California, Arizona, New
Mexico, and Texas. The purpose of the
activities of the cooperative agreements
is to accomplish the goals and objectives
of the US-Mexico Border Health
Commission. State border health offices
have both extensive experience working
with the Border Health Commission,
and have existing relationships and
ongoing initiatives with Mexican border
states. This experience and
relationships make the offices unique in
helping the Commission carry out its
VerDate Mar<15>2010
binational health initiatives and
activities along the border.
The supplemental funds are to
provide additional support for several
key activities of the cooperative
agreements. Because the activities are
ongoing, and being planned and carried
out by the State border health offices,
awarding the funds to the border health
offices is the only practicable way to
accomplish the objectives of enhancing
and extending the activities.
FOR FURTHER INFORMATION CONTACT:
Mark Geanacopoulos, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
59403
Hampshire Ave., Bldg. 51, rm. 6206,
Silver Spring, MD 20993–0002, 301–
796–6925.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors 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. Sponsors of
ANDAs 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 withdrawn 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 (21 CFR 314.162).
Under 314.161(a) (21 CFR 314.161(a)),
the Agency must determine whether a
listed drug was withdrawn from sale for
reasons of safety or effectiveness: (1)
Before an ANDA that refers to that listed
drug may be approved, (2) whenever a
listed drug is voluntarily withdrawn
from sale and ANDAs that refer to the
listed drug have been approved, and (3)
when a person petitions for such a
determination under 21 CFR 10.25(a)
and 10.30. Section 314.161(d) provides
that if FDA determines that a listed drug
was removed from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
As requested by the applicants, FDA
withdrew approval of NDA 012524 for
Enduron (methyclothiazide) Tablets and
NDA 017577 for Ditropan (oxybutynin
chloride) Tablets in the Federal Register
of March 19, 2012 (77 FR 16039). In
addition, FDA has become aware that
E:\FR\FM\27SEN1.SGM
27SEN1
59404
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Notices
the other drug products listed in the
table in this document are no longer
being marketed.
Application No.
Drug
Applicant
NDA 012524 ........................
Abbott Laboratories, 100 Abbott Park Rd., Abbott Park,
IL 60064–3500.
Valeant Pharmaceuticals International, Inc., 4787 Levy
St., Montreal, Quebec H4R 2P9, Canada.
NDA 017577 ........................
ENDURON (methyclothiazide) Tablets, 2.5 milligrams
(mg) and 5 mg.
LIMBITROL and LIMBITROL DS (amitriptyline hydrochloride; chlordiazepoxide) Tablets, equivalent to
(EQ) 12.5 mg (base), 5 mg, and EQ 25 mg (base),
10 mg.
DITROPAN (oxybutynin chloride) Tablets, 5 mg ............
NDA 017950 ........................
WESTCORT (hydrocortisone valerate) Cream, 0.2% ....
NDA 018763 ........................
TOPICORT (desoximetasone) Ointment, 0.25% ............
NDA 020036 ........................
AREDIA (pamidronate disodium) Injection, 30 mg/vial ..
NDA 020038 ........................
FLUDARA (fludarabine phosphate) Injection, 50 mg/vial
NDA 016949 ........................
FDA has reviewed its records and,
under 314.161, has determined that the
drug products listed in this document
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue
to list the drug products listed in this
document in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. Additional ANDAs that
refer to these products may also be
approved by the Agency if they comply
with relevant legal and regulatory
requirements. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: September 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23779 Filed 9–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
erowe on DSK2VPTVN1PROD with
[Docket No. FDA–2012–N–0001]
Food Defense; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
VerDate Mar<15>2010
15:00 Sep 26, 2012
Jkt 226001
Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., P.O. Box 200, Titusville, NJ 08560.
Ranbaxy Laboratories, Ltd., 600 College Road East,
suite 2100, Princeton, NJ 08540.
Taro Pharmaceuticals, Inc., 3 Skyline Dr., Hawthorne,
NY 10532.
Novartis Pharmaceuticals Corporation, One Health
Plaza, East Hanover, NJ 07936–1080.
Genzyme Corporation, 1850 K St. NW., suite 650,
Washington, DC 20006.
The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Office (SWRO), in cosponsorship with Oklahoma State
University (OSU), Robert M. Kerr Food
& Agricultural Products Center (FAPC),
is announcing a public workshop
entitled ‘‘Food Defense Workshop.’’
This public workshop is intended to
provide information about food defense
as it relates to food facilities such as
farms, manufacturers, processors,
distributors, retailers, and restaurants.
Date and Time: This public workshop
will be held on November 7 and 8, 2012,
from 7:45 a.m. to 4:15 p.m.
Location: The public workshop will
be held at the Robert M. Kerr Food &
Agricultural Products Center, Oklahoma
State University, 148 FAPC, Stillwater,
OK 74078–6055.
Contact: For information regarding
the workshop: David Arvelo, Food and
Drug Administration, Southwest
Regional Office, 4040 North Central
Expressway, suite 900, Dallas, TX
75204, 214–253–4952, Fax: 214–253–
4970, email: david.arvelo@fda.hhs.gov.
For information on accommodations:
Karen Smith or Andrea Graves at the
Robert M. Kerr Food & Agricultural
Products Center, Oklahoma State
University, 148 FAPC, Stillwater, OK
74078–6055, 405–744–6277, Fax: 405–
744–6313, or email:
karenl.smith@okstate.edu or
andrea.graves@okstate.edu. More
information is also available online at
https://www.fapc.biz/
fooddefense2012.html.
Registration: You are encouraged to
register by October 31, 2012. The
workshop has a registration fee to cover
the cost of facilities, materials, speakers,
and breaks. The registration fee is $350
for companies with 10 or more
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
employees or $250 for companies with
less than 10 employees. Seats are
limited; please submit your registration
as soon as possible. To register, please
complete the online registration form at
https://www.fapc.biz/
fooddefense2012.html. The workshop
will be filled in order of receipt of
registration. Those accepted into the
workshop will receive confirmation.
Registration will close after the
workshop is filled. Registration at the
site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 7:45 a.m. Make checks
payable to: ‘‘FAPC.’’ If you need special
accommodations due to a disability,
please contact Karen Smith (see
Contact) at least 7 days in advance.
There are no registration fees for FDA
employees.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested after the
date of the public workshop by
contacting Karen Smith or Andrea
Graves (see Contact) at cost plus
shipping.
This
public workshop is being held in
response to the large volume of food
defense inquiries from food
manufacturers originating from the area
covered by the FDA Dallas District
Office. The Southwest Regional Office
presents this workshop to help achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which include working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. This is
consistent with the purposes of the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 77, Number 188 (Thursday, September 27, 2012)]
[Notices]
[Pages 59403-59404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0190]
Determination That ENDURON (methyclothiazide) Tablets and Six
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that the
seven drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. This determination means
that FDA will not begin procedures to withdraw approval of abbreviated
new drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Mark Geanacopoulos, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6206, Silver Spring, MD 20993-0002, 301-
796-6925.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors 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. Sponsors of ANDAs 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 withdrawn 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 (21 CFR 314.162).
Under 314.161(a) (21 CFR 314.161(a)), the Agency must determine
whether a listed drug was withdrawn from sale for reasons of safety or
effectiveness: (1) Before an ANDA that refers to that listed drug may
be approved, (2) whenever a listed drug is voluntarily withdrawn from
sale and ANDAs that refer to the listed drug have been approved, and
(3) when a person petitions for such a determination under 21 CFR
10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines
that a listed drug was removed from sale for safety or effectiveness
reasons, the Agency will initiate proceedings that could result in the
withdrawal of approval of the ANDAs that refer to the listed drug.
As requested by the applicants, FDA withdrew approval of NDA 012524
for Enduron (methyclothiazide) Tablets and NDA 017577 for Ditropan
(oxybutynin chloride) Tablets in the Federal Register of March 19, 2012
(77 FR 16039). In addition, FDA has become aware that
[[Page 59404]]
the other drug products listed in the table in this document are no
longer being marketed.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 012524.................. ENDURON Abbott Laboratories,
(methyclothiazide) 100 Abbott Park
Tablets, 2.5 Rd., Abbott Park,
milligrams (mg) and IL 60064-3500.
5 mg.
NDA 016949.................. LIMBITROL and Valeant
LIMBITROL DS Pharmaceuticals
(amitriptyline International,
hydrochloride; Inc., 4787 Levy
chlordiazepoxide) St., Montreal,
Tablets, equivalent Quebec H4R 2P9,
to (EQ) 12.5 mg Canada.
(base), 5 mg, and
EQ 25 mg (base), 10
mg.
NDA 017577.................. DITROPAN (oxybutynin Janssen
chloride) Tablets, Pharmaceuticals,
5 mg. Inc., 1125 Trenton-
Harbourton Rd.,
P.O. Box 200,
Titusville, NJ
08560.
NDA 017950.................. WESTCORT Ranbaxy
(hydrocortisone Laboratories, Ltd.,
valerate) Cream, 600 College Road
0.2%. East, suite 2100,
Princeton, NJ
08540.
NDA 018763.................. TOPICORT Taro
(desoximetasone) Pharmaceuticals,
Ointment, 0.25%. Inc., 3 Skyline
Dr., Hawthorne, NY
10532.
NDA 020036.................. AREDIA (pamidronate Novartis
disodium) Pharmaceuticals
Injection, 30 mg/ Corporation, One
vial. Health Plaza, East
Hanover, NJ 07936-
1080.
NDA 020038.................. FLUDARA (fludarabine Genzyme Corporation,
phosphate) 1850 K St. NW.,
Injection, 50 mg/ suite 650,
vial. Washington, DC
20006.
------------------------------------------------------------------------
FDA has reviewed its records and, under 314.161, has determined
that the drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. Accordingly, the Agency
will continue to list the drug products listed in this document in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' identifies, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness.
Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: September 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23779 Filed 9-26-12; 8:45 am]
BILLING CODE 4160-01-P
