Determination That PFIZERPEN (Penicillin G Potassium) Injection, 1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 73599-73600 [2014-29034]
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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
73599
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
2017–2018 Data Collection (Fast Food Restaurants)—Completion of Sections 1 and
3.
2017–2018 Data Collection (Full Service
Restaurants)—Completion of Sections 1
and 3.
2017–2018 Data Collection-Completion of
Section 2—All Facility
Types.
2017–2018 Data Collection-Entry Refusals—
All Facility Types.
400
1
400
1.36 ...........
544
400
1
400
1.73 ...........
692
800
1
800
0.5 (30 minutes).
400
0.08 (5 minutes).
1.28
...............
1,637.28
Number of
nonrespondents
16
Number of
responses
per nonrespondent
Total annual
nonresponses
1
16
Total hours ............
1 There
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. FDA Food Code. Available at:
https://www.fda.gov/Food/
GuidanceRegulation/
RetailFoodProtection/FoodCode/
default.htm.
Dated: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29065 Filed 12–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0320]
mstockstill on DSK4VPTVN1PROD with NOTICES
Determination That PFIZERPEN
(Penicillin G Potassium) Injection, 1
Million Units/Vial, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
Food and Drug Administration,
HHS.
ACTION:
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
II. Reference
AGENCY:
Average
burden per
response
Notice.
The Food and Drug
Administration (FDA) has determined
that PFIZERPEN (penicillin G
potassium) Injection, 1 million units/
SUMMARY:
VerDate Sep<11>2014
19:07 Dec 10, 2014
Jkt 235001
vial, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for penicillin G
potassium injection, 1 million units/
vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6250,
Silver Spring, MD 20993–0002, 301–
796–3601.
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 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 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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Therapeutic Equivalence Evaluations,’’
which is known generally 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 (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (21 CFR 314.161). FDA may
not approve an ANDA that does not
refer to a listed drug.
PFIZERPEN (penicillin G potassium)
Injection, 1 million units/vial, is the
subject of ANDA 60–657, held by Pfizer,
Inc., and initially approved on August
30, 1968. ANDA 60–657 is considered
the designated reference standard.
PFIZERPEN is indicated in the
treatment of serious infections caused
by susceptible strains of the designated
microorganisms in certain conditions
such as septicemia, pneumonia,
meningitis, anthrax, and listeria.
PFIZERPEN (penicillin G potassium)
Injection, 1 million units/vial, is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. Lachman Consultant Services,
Inc., submitted a citizen petition dated
May 27, 2008 (Docket No. FDA–2008–
P–0320), under 21 CFR 10.30,
E:\FR\FM\11DEN1.SGM
11DEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
73600
Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices
requesting that the Agency determine
whether PFIZERPEN (penicillin G
potassium) Injection, 1 units/vial, and
penicillin G potassium injection, 1
million units/vial, had been withdrawn
from sale for reasons of safety or
effectiveness. Penicillin G potassium
Injection, 1 million units/vial, is the
subject of ANDA 65–079, held by
Sandoz, and approved on August 30,
2002.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PFIZERPEN (penicillin G
potassium) Injection, 1 million units/
vial, was not withdrawn for reasons of
safety or effectiveness (this
determination also applies to penicillin
G potassium injection, 1 million units/
vial, ANDA 65–079). The petitioner
believes that PFIZERPEN (penicillin G
potassium) Injection, 1 million units/
vial, was not withdrawn for reasons of
safety or effectiveness because it was
discontinued due to commercial
reasons. We have carefully reviewed our
files for records concerning the
withdrawal of PFIZERPEN (penicillin G
potassium) Injection, 1 million units/
vial, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PFIZERPEN (penicillin
G potassium) Injection, 1 million units/
vial, 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 PFIZERPEN (penicillin G potassium)
Injection, 1 million units/vial, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29034 Filed 12–10–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:07 Dec 10, 2014
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Budesonide Extended-Release
Tablets; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendations for Budesonide
Extended-Release Tablets.’’ The
guidance provides specific
recommendations on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for budesonide extendedrelease tablets.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 9,
2015.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kris
´
Andre, Center for Drug Evaluation and
Research (HFD–600), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1615, Silver Spring,
MD 20993–0002, 240–402–7290.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm. As described in
that guidance, FDA adopted this process
as a means to develop and disseminate
product-specific BE recommendations
and to provide a meaningful
opportunity for the public to consider
and comment on those
recommendations. This notice
announces the availability of draft BE
recommendations for budesonide
extended-release tablets.
New drug application 203634 for
UCERIS (budesonide) extended-release
tablets, 9 milligrams (mg), was initially
approved by FDA in January 2013. FDA
is now issuing a draft guidance for
industry on BE recommendations for
generic budesonide extended-release
tablets.
In February 2013, Santarus, Inc.,
submitted a citizen petition requesting
that FDA: (1) Issue an individual BE
guidance for budesonide extendedrelease tablets and (2) refrain from
approving any ANDA that identifies
UCERIS (budesonide) extended-release
tablets as the reference listed drug
unless the generic product is shown to
be bioequivalent based on appropriate
data from a clinical efficacy endpoint
study, comparative pharmacokinetic
testing, in vitro dissolution testing, and
pharmacoscintigraphy studies (Docket
No. FDA 2013–P–0127). FDA reviewed
the issues raised in the petition and is
responding to the petition today in a
letter that will be included in the citizen
petition docket.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for budesonide extended-release
tablets. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
E:\FR\FM\11DEN1.SGM
11DEN1
]]>Agencies
[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73599-73600]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29034]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0320]
Determination That PFIZERPEN (Penicillin G Potassium) Injection,
1 Million Units/Vial, Was 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
PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for penicillin G potassium injection, 1 million
units/vial, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.
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 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 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 known generally 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 (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial,
is the subject of ANDA 60-657, held by Pfizer, Inc., and initially
approved on August 30, 1968. ANDA 60-657 is considered the designated
reference standard. PFIZERPEN is indicated in the treatment of serious
infections caused by susceptible strains of the designated
microorganisms in certain conditions such as septicemia, pneumonia,
meningitis, anthrax, and listeria.
PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial,
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book. Lachman Consultant Services, Inc., submitted a
citizen petition dated May 27, 2008 (Docket No. FDA-2008-P-0320), under
21 CFR 10.30,
[[Page 73600]]
requesting that the Agency determine whether PFIZERPEN (penicillin G
potassium) Injection, 1 units/vial, and penicillin G potassium
injection, 1 million units/vial, had been withdrawn from sale for
reasons of safety or effectiveness. Penicillin G potassium Injection, 1
million units/vial, is the subject of ANDA 65-079, held by Sandoz, and
approved on August 30, 2002.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that PFIZERPEN (penicillin G potassium) Injection,
1 million units/vial, was not withdrawn for reasons of safety or
effectiveness (this determination also applies to penicillin G
potassium injection, 1 million units/vial, ANDA 65-079). The petitioner
believes that PFIZERPEN (penicillin G potassium) Injection, 1 million
units/vial, was not withdrawn for reasons of safety or effectiveness
because it was discontinued due to commercial reasons. We have
carefully reviewed our files for records concerning the withdrawal of
PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this product was not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list PFIZERPEN (penicillin
G potassium) Injection, 1 million units/vial, 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 PFIZERPEN (penicillin G potassium)
Injection, 1 million units/vial, may be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29034 Filed 12-10-14; 8:45 am]
BILLING CODE 4164-01-P
