Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON, 38911-38912 [2017-17301]
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Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
348–3035.
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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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time after the drug has been withdrawn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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CORDARONE (amiodarone
hydrochloride) tablets, 200 mg, are the
subject of NDA 018972, held by Wyeth
Pharmaceuticals, Inc. (a subsidiary of
Pfizer, Inc.), and initially approved on
December 24, 1985. CORDARONE is
indicated for the treatment of the
following documented, life-threatening
recurrent ventricular arrhythmias when
these have not responded to
documented adequate doses of other
available antiarrhythmics or when
alternative agents could not be tolerated:
(1) Recurrent ventricular fibrillation and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:33 Aug 15, 2017
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(2) recurrent hemodynamically unstable
ventricular tachycardia.
In correspondence dated February 7,
2017, Pfizer, Inc. notified FDA that
CORDARONE (amiodarone
hydrochloride) tablets, 200 mg, were
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Lachman Consultant Services, Inc.
submitted a citizen petition dated
January 25, 2017 (Docket No. FDA–
2017–P–0495), under 21 CFR 10.30,
requesting that the Agency determine
whether CORDARONE (amiodarone
hydrochloride) tablets, 200 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 CORDARONE
(amiodarone hydrochloride) tablets, 200
mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that
CORDARONE (amiodarone
hydrochloride) tablets, 200 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
CORDARONE (amiodarone
hydrochloride) tablets, 200 mg, 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 drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list CORDARONE
(amiodarone hydrochloride) tablets, 200
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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also 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.
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38911
Dated: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–17302 Filed 8–15–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3966]
Upsher-Smith Laboratories, Inc.;
Withdrawal of Approval of an
Abbreviated New Drug Application for
ZALEPLON
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of an abbreviated
new drug application (ANDA) for
ZALEPLON Capsules, 5 milligrams (mg)
and 10 mg, held by Upsher-Smith
Laboratories, Inc. (Upsher-Smith), 6701
Evenstad Dr., Maple Grove, MN 55369.
Upsher-Smith has voluntarily requested
that approval of this application be
withdrawn, and has waived its
opportunity for a hearing.
DATES: Effective August 16, 2017.
FOR FURTHER INFORMATION CONTACT:
Stefanie Kraus, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215,
Silver Spring, MD 20993–0002, 301–
796–9585.
SUPPLEMENTARY INFORMATION: On June 6,
2008, FDA approved ANDA 078706 for
ZALEPLON Capsules, 5 mg and 10 mg,
submitted by Upsher-Smith. According
to annual reports Upsher-Smith filed
with the Agency, Upsher-Smith stopped
distributing these products by April 6,
2010. In a letter dated August 9, 2011,
FDA informed Upsher-Smith that it had
concerns about the validity of
bioequivalence data submitted with
ANDA 078706 from studies conducted
by a certain contract research
organization, establishing
bioequivalence of Upsher-Smith’s
product to the reference listed drug,
SONATA (ZALEPLON) Capsules, 5 mg
and 10 mg. In that letter, FDA directed
Upsher-Smith to supplement its ANDA
with either: (1) New bioequivalence
studies or (2) re-assays of the samples
from the original bioequivalence
studies. Upsher-Smith did not respond
to this letter. FDA then sent another
letter to Upsher-Smith on August 19,
SUMMARY:
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38912
Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices
2016, requesting that Upsher-Smith
provide the requested bioequivalence
data within 30 calendar days or
voluntarily seek withdrawal of ANDA
078706 under section 314.150(d) (21
CFR 314.150(d)).
In a letter dated September 15, 2016,
Upsher-Smith informed FDA that it did
not intend to submit the requested
bioequivalence data and requested that
the Agency withdraw approval of
ANDA 078706 for ZALEPLON Capsules
under section 314.150(d). In that letter,
Upsher-Smith also waived any
opportunity for a hearing otherwise
provided under section 314.150(a).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
314.150(d), approval of ANDA 078706,
and all amendments and supplements
thereto, is withdrawn (see DATES).
Distribution of this product in 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.
355(a) and 331(d)).
Dated: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–17301 Filed 8–15–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Appointment to the Tick-Borne
Disease Working Group; Amendment
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice; amendment.
AGENCY:
A notice was published in the
Federal Register on Monday, July 17,
2017 (Vol. 82, No. 135, pages 32711–
32712), to solicit nominations of
individuals who are interested in being
considered for appointment to the TickBorne Disease Working Group (Working
Group). The nomination period is
scheduled to end close of business on
August 16, 2017. The notice is being
amended to extend the solicitation
period for one week to allow more time
for interested individuals to submit
nominations.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
The solicitation period has been
extended. All nominations are due to be
submitted on or before August 23, 2017.
ADDRESSES: All nominations should be
sent to: CAPT Richard Henry; Office of
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Dated: August 10, 2017.
Donald Wright,
Acting Assistant Secretary for Health.
[FR Doc. 2017–17323 Filed 8–15–17; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(Advisory Council). The meeting will be
open to the public; a public comment
session will be held during the meeting.
Pre-registration is required for members
of the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should send an email to CARB@hhs.gov.
Registration information is available on
the Web site https://www.hhs.gov/ash/
carb/ and must be completed by
September 5, 2017; all in-person
attendees must pre-register by this date.
Additional information about registering
for the meeting and providing public
comment can be obtained at https://
www.hhs.gov/ash/carb/ on the Meetings
page.
DATES: The meeting is scheduled to be
held on September 13, 2017, from 9:00
a.m. to 5:00 p.m. ET, and September 14,
2017, from 9:00 a.m. to 3:00 p.m. ET
(times are tentative and subject to
change). The confirmed times and
agenda items for the meeting will be
posted on the Web site for the Advisory
SUMMARY:
BILLING CODE 4164–01–P
DATES:
the Assistant Secretary for Health;
Department of Health and Human
Services; 330 C Street SW., Suite L100,
Washington, DC 20024. Nomination
materials, including attachments, also
may be submitted electronically to
tickbornedisease@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
CAPT Richard Henry, Office of the
Assistant Secretary for Health;
Department of Health and Human
Services; Telephone: (202) 795–7615;
Email address: richard.henry@hhs.gov.
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Council at https://www.hhs.gov/ash/
carb/ when this information becomes
available. Pre-registration for attending
the meeting in person is required to be
completed no later than September 5,
2017; public attendance at the meeting
is limited to the available space.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
The meeting can also be accessed
through a live webcast on the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, Acting Designated
Federal Officer, Presidential Advisory
Council on Combating AntibioticResistant Bacteria, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
Phone: (202) 690–5566; email: CARB@
hhs.gov.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
E:\FR\FM\16AUN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Pages 38911-38912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3966]
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for ZALEPLON
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of an abbreviated new drug application (ANDA) for
ZALEPLON Capsules, 5 milligrams (mg) and 10 mg, held by Upsher-Smith
Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN
55369. Upsher-Smith has voluntarily requested that approval of this
application be withdrawn, and has waived its opportunity for a hearing.
DATES: Effective August 16, 2017.
FOR FURTHER INFORMATION CONTACT: Stefanie Kraus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-9585.
SUPPLEMENTARY INFORMATION: On June 6, 2008, FDA approved ANDA 078706
for ZALEPLON Capsules, 5 mg and 10 mg, submitted by Upsher-Smith.
According to annual reports Upsher-Smith filed with the Agency, Upsher-
Smith stopped distributing these products by April 6, 2010. In a letter
dated August 9, 2011, FDA informed Upsher-Smith that it had concerns
about the validity of bioequivalence data submitted with ANDA 078706
from studies conducted by a certain contract research organization,
establishing bioequivalence of Upsher-Smith's product to the reference
listed drug, SONATA (ZALEPLON) Capsules, 5 mg and 10 mg. In that
letter, FDA directed Upsher-Smith to supplement its ANDA with either:
(1) New bioequivalence studies or (2) re-assays of the samples from the
original bioequivalence studies. Upsher-Smith did not respond to this
letter. FDA then sent another letter to Upsher-Smith on August 19,
[[Page 38912]]
2016, requesting that Upsher-Smith provide the requested bioequivalence
data within 30 calendar days or voluntarily seek withdrawal of ANDA
078706 under section 314.150(d) (21 CFR 314.150(d)).
In a letter dated September 15, 2016, Upsher-Smith informed FDA
that it did not intend to submit the requested bioequivalence data and
requested that the Agency withdraw approval of ANDA 078706 for ZALEPLON
Capsules under section 314.150(d). In that letter, Upsher-Smith also
waived any opportunity for a hearing otherwise provided under section
314.150(a).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and 314.150(d), approval of
ANDA 078706, and all amendments and supplements thereto, is withdrawn
(see DATES). Distribution of this product in 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.
355(a) and 331(d)).
Dated: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17301 Filed 8-15-17; 8:45 am]
BILLING CODE 4164-01-P
