Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 72728-72729 [2015-29639]
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72728
Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
21, 2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0726. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Improving Food Safety and Defense
Capacity at the State and Local Level:
Review of State and Local Capacities
OMB Control Number 0910–0726—
Extension
The Food Safety Modernization Act
(FSMA) (Pub. L. 111–353) states that a
review must be conducted to assess the
State and local capacities to show needs
for enhancement in the areas or staffing
levels, laboratory capacities, and
information technology systems. This
mandate referenced in FSMA section
110 stating that a review of current food
safety and food defense capabilities
must be presented to Congress no later
than 2 years after the date of enactment
(enactment date January 4, 2011). This
review was completed in 2013 through
this information collection request.
This collection provided a baseline
measurement of the nation’s current
food safety and food defense
capabilities; FDA wants to renew this
information collection to gather more
data. By renewing this collection, FDA
will be able to analyze the gaps and
trends at the State and local levels,
allowing FDA and its partners to
develop ways to create a national
integrated food safety system.
FDA will conduct the survey
electronically, allowing FDA to conduct
streamlined analysis while creating a
low-burden, user-friendly environment
for respondents to complete the survey.
Once the results have been tabulated,
FDA and its partners can assess the
current progress towards an integrated
food safety system.
In the Federal Register of August 31,
2015 (80 FR 46025), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Current State and Local Government Employees ...............
1,400
1
1,400
1
1,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
(mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg,
and 10 mg/80 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
ezetimibe and atorvastatin tablets, 10
mg/10 mg, 10 mg/20 mg, 10 mg/40 mg,
and 10 mg/80 mg, if all other legal and
regulatory requirements are met.
[FR Doc. 2015–29663 Filed 11–19–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
Determination That LIPTRUZET
(Ezetimibe and Atorvastatin) Tablets,
10 Milligrams/10 Milligrams, 10
Milligrams/20 Milligrams, 10
Milligrams/40 Milligrams, and 10
Milligrams/80 Milligrams, 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 or Agency) has
determined that LIPTRUZET (ezetimibe
and atorvastatin) tablets, 10 milligrams
SUMMARY:
VerDate Sep<11>2014
17:39 Nov 19, 2015
Jkt 238001
Kate
Greenwood, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6217, Silver Spring,
MD 20993–0002, 240–402–1748.
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2015–P–3404]
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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
E:\FR\FM\20NON1.SGM
20NON1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
LIPTRUZET (ezetimibe and
atorvastatin) tablets, 10 mg/10 mg, 10
mg/20 mg, 10 mg/40 mg, and 10 mg/80
mg, are the subject of NDA 20–0153,
held by Merck Sharp & Dohme Corp.,
and initially approved on May 3, 2013.
LIPTRUZET is indicated for the
reduction of elevated total cholesterol
(total-C), low-density lipoprotein
cholesterol (LDL–C), apolipoprotein B
(Apo B), triglycerides (TG), and nonhigh-density lipoprotein cholesterol
(non-HDL–C), and to increase highdensity lipoprotein cholesterol (HDL–C)
in patients with primary (heterozygous
familial and non-familial)
hyperlipidemia or mixed
hyperlipidemia. LIPTRUZET is also
indicated for the reduction of elevated
total-C and LDL–C in patients with
homozygous familial
hypercholesterolemia, as an adjunct to
other lipid-lowering treatments (e.g.,
LDL apheresis) or if such treatments are
unavailable.
In a letter dated June 1, 2015, Merck
Sharpe & Dohme Corp. notified FDA
that LIPTRUZET (ezetimibe and
atorvastatin) tablets, 10 mg/10 mg, 10
mg/20 mg, 10 mg/40 mg, and 10 mg/80
mg, were being discontinued, and FDA
moved the drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lupin Pharmaceuticals, Inc.
submitted a citizen petition dated
September 21, 2015 (Docket No. FDA–
2015–P–3404), under 21 CFR 10.30,
requesting that the Agency determine
whether LIPTRUZET (ezetimibe and
atorvastatin) tablets, 10 mg/10 mg, 10
mg/20 mg, 10 mg/40 mg, and 10 mg/80
mg, were withdrawn from sale for
reasons of safety or effectiveness.
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 LIPTRUZET (ezetimibe
and atorvastatin) tablets, 10 mg/10 mg,
10 mg/20 mg, 10 mg/40 mg, and 10 mg/
80 mg, were not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that LIPTRUZET
(ezetimibe and atorvastatin) tablets, 10
mg/10 mg, 10 mg/20 mg, 10 mg/40 mg,
and 10 mg/80 mg, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
LIPTRUZET (ezetimibe and atorvastatin)
tablets, 10 mg/10 mg, 10 mg/20 mg, 10
mg/40 mg, and 10 mg/80 mg, from sale.
VerDate Sep<11>2014
17:39 Nov 19, 2015
Jkt 238001
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that these products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list LIPTRUZET (ezetimibe
and atorvastatin) tablets, 10 mg/10 mg,
10 mg/20 mg, 10 mg/40 mg, and 10 mg/
80 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 LIPTRUZET
(ezetimibe and atorvastatin) tablets, 10
mg/10 mg, 10 mg/20 mg, 10 mg/40 mg,
and 10 mg/80 mg, 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 these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29639 Filed 11–19–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of In Vitro
Diagnostics for the Detection of
Diseases or Pathogenic Agents
National Institute of Diabetes
and Digestive and Kidney Diseases,
National Institutes of Health, Public
Health Service, HHS.
ACTION: Notice.
AGENCY:
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), at the
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant to
Omega Diagnostics Group PLC
(‘‘Omega’’), a company incorporated
under the laws of the United Kingdom,
having an office in Alva, Scotland, an
exclusive patent license to practice the
following inventions embodied in the
following patent applications: US
Provisional Patent Application No.60/
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
72729
846,354, entitled, ‘‘(S,S)-trans-1,2cyclopentane Diamine-modified and
Gamma-lysine-modified Peptide
Nucleic Acids as Probes for Nucleic
Acid Detection: Synthesis and
Applications,’’ filed 22 Sep 2006 [HHS
Ref No. E–308–2006/0–US–01]; US
Provisional Patent Application No. 60/
896,667, entitled, ‘‘Synthesis of Transtert-butyl-2aminocyclopentylcarbamate,’’ filed 23
Mar 2007 [HHS Ref No. E–308–2006/1–
US–01]; International Application PCT/
US2007/020466, entitled, ‘‘Synthesis of
Trans-tert-butyl-2aminocyclopentylcarbamate,’’ filed 21
Sep 2007 [HHS Ref No. E–308–2006/2–
PCT–01]; US Patent Application No. 12/
441,925, filed 21 Sep 2007, [HHS Ref
No. E–308–2006/2–US–02]; US Patent
Application No. 12/409,159, entitled,
‘‘Cross-Coupled Peptide Nucleic Acids
for Detection of Nucleic Acids of
Pathogens,’’ filed 23 Mar 2009 [HHS Ref
No. E–308–2006/3–US–01]; US Patent
No. 9,156,778, entitled, ‘‘Cross-Coupled
Peptide Nucleic Acids for Detection of
Nucleic Acids of Pathogens,’’ issued 13
Oct 2015 [HHS Ref No. E–308–2006/3–
US–02]; US Provisional Patent
Application No. 61/684,354, entitled,
Cyclopentane-peptide Nucleic Acids for
Qualitative and Quantitative Detection
of Nucleic Acids,’’ filed 17 Aug 2012
[HHS Ref No. E–260–2012/0–US–01];
International Application PCT/US2013/
055252, filed 16 Aug 2013 [HHS Ref No.
E–260–2012/0–PCT–02]; European
Patent Application No. 13753962.3,
filed 11 Feb 2015, [HHS Ref No E–260–
2012/0–EP–03]; Korea Patent
Application No. 10–2015–7006286, filed
11 Mar 2015, [HHS Ref No E–260–2012/
0–KR–04]; and US Patent Application
No. 14/421,732, filed 13 Feb 2015, [HHS
Ref No E–260–2012/0–US–05].
The patent rights in these inventions
have been assigned to the United States
of America. Omega is seeking a
worldwide territory for this license. The
field of use may be limited to use of the
Patent Rights for the development and
sale of trans-cyclopentane-modified
peptide nucleic acids (PNA) in a
diagnostic system incorporating an
enzyme-linked immunosorbent assay or
Omega’s proprietary VISITECT®
technology for the detection of diseases
or pathogenic agents including viruses
and microorganisms.
DATES: Only written comments or
applications for a license (or both)
which are received by the Technology
Advancement Office, NIDDK, on or
before December 7, 2015 will be
considered.
ADDRESSES: Requests for copies of the
patent application, patents, inquiries,
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72728-72729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29639]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-P-3404]
Determination That LIPTRUZET (Ezetimibe and Atorvastatin)
Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10
Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, 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 or Agency) has
determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10
milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 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 ezetimibe and atorvastatin tablets, 10 mg/10
mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 240-
402-1748.
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
[[Page 72729]]
from sale, but must be made prior to approving an ANDA that refers to
the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve
an ANDA that does not refer to a listed drug.
LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/
20 mg, 10 mg/40 mg, and 10 mg/80 mg, are the subject of NDA 20-0153,
held by Merck Sharp & Dohme Corp., and initially approved on May 3,
2013. LIPTRUZET is indicated for the reduction of elevated total
cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C),
apolipoprotein B (Apo B), triglycerides (TG), and non-high-density
lipoprotein cholesterol (non-HDL-C), and to increase high-density
lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous
familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
LIPTRUZET is also indicated for the reduction of elevated total-C and
LDL-C in patients with homozygous familial hypercholesterolemia, as an
adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if
such treatments are unavailable.
In a letter dated June 1, 2015, Merck Sharpe & Dohme Corp. notified
FDA that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg,
10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were being discontinued, and
FDA moved the drug products to the ``Discontinued Drug Product List''
section of the Orange Book.
Lupin Pharmaceuticals, Inc. submitted a citizen petition dated
September 21, 2015 (Docket No. FDA-2015-P-3404), under 21 CFR 10.30,
requesting that the Agency determine whether LIPTRUZET (ezetimibe and
atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10
mg/80 mg, were withdrawn from sale for reasons of safety or
effectiveness.
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 LIPTRUZET (ezetimibe and atorvastatin)
tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that LIPTRUZET
(ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/
40 mg, and 10 mg/80 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of LIPTRUZET (ezetimibe and atorvastatin)
tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have found no information
that would indicate that these products were withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list LIPTRUZET (ezetimibe
and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and
10 mg/80 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
LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20
mg, 10 mg/40 mg, and 10 mg/80 mg, 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 these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29639 Filed 11-19-15; 8:45 am]
BILLING CODE 4164-01-P
