MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products, 54729-54730 [2014-21729]
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Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Notices
54729
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2013–N–0485]
[Docket No. FDA–2013–N–1422]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Electronic Submission of Allegations
of Regulatory Misconduct Associated
With Medical Devices
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Eye Tracking Study of Direct-toConsumer Prescription Drug
Advertisement Viewing
[Docket No. FDA–2014–N–0199]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Food and Drug Administration,
HHS.
Notice.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Electronic Submission of Allegations
of Regulatory Misconduct Associated
with Medical Devices’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
On May
27, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Electronic Submission of
Allegations of Regulatory Misconduct
Associated with Medical Devices’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0769. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: September 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Dated: September 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21769 Filed 9–11–14; 8:45 am]
[FR Doc. 2014–21728 Filed 9–11–14; 8:45 am]
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The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Eye Tracking Study of Direct-toConsumer Prescription Drug
Advertisement Viewing’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
On June
30, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Eye Tracking Study of Directto-Consumer Prescription Drug
Advertisement Viewing’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0772. The approval expires on
August 31, 2017. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
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MK Laboratories, Inc., et al.;
Withdrawal of Approval of 3
Abbreviated New Drug Applications for
Propoxyphene Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of three abbreviated new drug
applications (ANDAs) for products
containing propoxyphene. The basis for
the withdrawals is that the products are
no longer shown to be safe because
propoxyphene puts patients at risk of
potentially serious and even fatal heart
rhythm abnormalities. The holders of
these ANDAs have waived their
opportunity for a hearing.
DATES: Effective September 12, 2014.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 51, Rm. 6254, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: On
November 18, 2010, after receiving
clinical data and other information
showing that propoxyphene puts
patients at risk of potentially serious
and even fatal heart rhythm
abnormalities, FDA asked
manufacturers of then marketed
branded and generic propoxyphene
drug products to voluntarily withdraw
the products from the U.S. market. In a
notice published in the Federal Register
of March 10, 2014 (79 FR 13308), FDA
withdrew approval of 8 new drug
applications (NDAs) and 46 ANDAs for
propoxyphene drug products from
multiple sources whose application
holders agreed in writing to waive their
opportunity for a hearing and permit
FDA to withdraw approval of the
applications. In a separate notice
published in the Federal Register of
March 10, 2014 (79 FR 13310), FDA’s
Center for Drug Evaluation and Research
(CDER) notified the holders of 3 other
approved ANDAs for propoxyphene
drug products of their opportunity to
request a hearing on CDER’s proposal to
issue an order, under section 505(e) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 355(e)),
withdrawing approval of 3 ANDAs for
propoxyphene drug products. The
following products, all of which FDA
SUMMARY:
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54730
Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Notices
believes were discontinued prior to
November 2010, were listed in the
notice.
TABLE 1—PROPOXYPHENE DRUG PRODUCT APPLICATIONS FOR WHICH FDA PROPOSED TO WITHDRAW APPROVAL
Application No.
Drug
Applicant or holder
ANDA 083544 ....
Kesso-Gesic (propoxyphene hydrochloride (HCl)) Capsules,
65 milligrams (mg).
Propoxyphene HCl Capsules, 65 mg ......................................
Compound 65 (aspirin, caffeine, and propoxyphene HCl)
Capsules, 389 mg/32.4 mg/65 mg.
MK Laboratories Inc., 424 Grasmere Ave., Fairfield, CT
06430.
Whiteworth Towne Paulsen Inc.
Alra Labs, 3850 Clearview Ct., Gurnee, IL 60031.
ANDA 084551 ....
ANDA 084553 ....
In its March 10, 2014, notice of
opportunity for a hearing, CDER
provided these ANDA holders an
opportunity to request a hearing to show
why approval of the ANDAs should not
be withdrawn. No timely request for a
hearing on this matter was received
following publication of the notice in
the Federal Register.
Therefore, under section 505(e) of the
FD&C Act and under authority
delegated to the Director of CDER by the
Commissioner of Food and Drugs,
approval of the applications listed in
table 1 and all amendments and
supplements thereto is withdrawn (see
DATES). Introduction or delivery for
introduction of these products into
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. 331(d))).
Dated: September 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21729 Filed 9–11–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. This
meeting was announced in the Federal
Register of April 25, 2014 (79 FR
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:58 Sep 11, 2014
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22995). The amendment is being made
to reflect a change in the Agenda
portion of the document. There are no
other changes.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Submission for OMB Review; 30-Day
Comment Request Food and Drug
Administration (FDA) and the National
Cancer Institute (NCI) Health
Communication Survey (FDA–NCI)
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
PDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
In the
Federal Register of April 25, 2014, FDA
announced that a meeting of the Joint
Meeting of the Psychopharmacologic
Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee would be held on October
16, 2014. On page 22996, in the first
column, the Agenda portion of the
document is changed to read as follows:
Agenda: The committees will discuss
safety data from observational studies
and a meta-analysis of randomized
controlled clinical trials that have been
conducted since the original signal of
serious neuropsychiatric adverse events
with CHANTIX (varenicline tartrate
tablets, NDA 21928, Pfizer, Inc.)
emerged. The committees will also
discuss whether any action needs to be
taken with regard to how this risk is
described in product labeling.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
SUPPLEMENTARY INFORMATION:
Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21780 Filed 9–11–14; 8:45 am]
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National Institutes of Health
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on May 8, 2014,
Vol. 79, No. 89, page 26439 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments To OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Bradford W. Hesse, Ph.D.,
Health Communication and Informatics
Research Branch, 9609 Medical Center
SUMMARY:
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[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Pages 54729-54730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0199]
MK Laboratories, Inc., et al.; Withdrawal of Approval of 3
Abbreviated New Drug Applications for Propoxyphene Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three abbreviated new drug applications (ANDAs) for products
containing propoxyphene. The basis for the withdrawals is that the
products are no longer shown to be safe because propoxyphene puts
patients at risk of potentially serious and even fatal heart rhythm
abnormalities. The holders of these ANDAs have waived their opportunity
for a hearing.
DATES: Effective September 12, 2014.
FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.
SUPPLEMENTARY INFORMATION: On November 18, 2010, after receiving
clinical data and other information showing that propoxyphene puts
patients at risk of potentially serious and even fatal heart rhythm
abnormalities, FDA asked manufacturers of then marketed branded and
generic propoxyphene drug products to voluntarily withdraw the products
from the U.S. market. In a notice published in the Federal Register of
March 10, 2014 (79 FR 13308), FDA withdrew approval of 8 new drug
applications (NDAs) and 46 ANDAs for propoxyphene drug products from
multiple sources whose application holders agreed in writing to waive
their opportunity for a hearing and permit FDA to withdraw approval of
the applications. In a separate notice published in the Federal
Register of March 10, 2014 (79 FR 13310), FDA's Center for Drug
Evaluation and Research (CDER) notified the holders of 3 other approved
ANDAs for propoxyphene drug products of their opportunity to request a
hearing on CDER's proposal to issue an order, under section 505(e) of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
355(e)), withdrawing approval of 3 ANDAs for propoxyphene drug
products. The following products, all of which FDA
[[Page 54730]]
believes were discontinued prior to November 2010, were listed in the
notice.
Table 1--Propoxyphene Drug Product Applications for Which FDA Proposed
To Withdraw Approval
------------------------------------------------------------------------
Application No. Drug Applicant or holder
------------------------------------------------------------------------
ANDA 083544............ Kesso-Gesic MK Laboratories Inc.,
(propoxyphene 424 Grasmere Ave.,
hydrochloride (HCl)) Fairfield, CT 06430.
Capsules, 65
milligrams (mg).
ANDA 084551............ Propoxyphene HCl Whiteworth Towne
Capsules, 65 mg. Paulsen Inc.
ANDA 084553............ Compound 65 (aspirin, Alra Labs, 3850
caffeine, and Clearview Ct.,
propoxyphene HCl) Gurnee, IL 60031.
Capsules, 389 mg/32.4
mg/65 mg.
------------------------------------------------------------------------
In its March 10, 2014, notice of opportunity for a hearing, CDER
provided these ANDA holders an opportunity to request a hearing to show
why approval of the ANDAs should not be withdrawn. No timely request
for a hearing on this matter was received following publication of the
notice in the Federal Register.
Therefore, under section 505(e) of the FD&C Act and under authority
delegated to the Director of CDER by the Commissioner of Food and
Drugs, approval of the applications listed in table 1 and all
amendments and supplements thereto is withdrawn (see DATES).
Introduction or delivery for introduction of these products into
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. 331(d))).
Dated: September 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21729 Filed 9-11-14; 8:45 am]
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