Determination That DORYX MPC (Doxycycline Hyclate), Delayed-Release Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 10493-10494 [2018-04726]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices
17. Meeting Summary and Attachment from
the U.S.-EU Bivalve Molluscan Shellfish
Equivalence Project. November 19–20,
2015. FDA Hillandale Building, Silver
Spring, MD.
18. Commission Regulation (EU) 2015/2285
of 8 December 2015 Amending Annex II
to Regulation (EC) No. 854/2004 of the
European Parliament. Accessed online at
https://eur-lex.europa.eu/legal-content/
EN/TXT/PDF/?uri=CELEX:32015R2285
&from=EN.
19. Meeting Summary and Attachment from
the U.S.-EU Bivalve Molluscan Shellfish
Equivalence Project. September 19–20,
2016. FDA Center for Food Safety and
Applied Nutrition, College Park, MD.
20. Bad Bug Book, Foodborne Pathogenic
Microorganisms and Natural Toxins.
Second Edition. FDA. 2012. Accessed
online at https://www.fda.gov/food/
foodborneillnesscontaminants/
causesofillnessbadbugbook/.
21. Risk Assessment of Vibrio vulnificus in
Raw Oysters, Interpretive Summary and
Technical Report. World Health
Organization/Food and Agriculture
Organization of the United Nations.
2005. Accessed online at https://
www.who.int/foodsafety/publications/
micro/mra8.pdf.
22. Meeting Summary and Attachments from
the U.S.-EU Molluscan Shellfish
Equivalence Project. September 5–6,
2013. FDA White Oak Campus, Silver
Spring, MD.
23. On-going Activities on Emerging Risks in
the SCER Unit. Presentation at European
Food Safety Authority (EFSA) 56th
Advisory Forum Meeting. June 11–12,
2015. Accessed online at https://
www.efsa.europa.eu/sites/default/files/
assets/af150611a-p9d.pdf.
Dated: March 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments’’ that appeared in
the Federal Register of February 22,
2018. The document was published
with the incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Thursday, February
22, 2018 (83 FR 7727), in FR Doc. 2018–
03603, on page 7727, the following
correction is made:
1. On page 7727, in the first column,
in the header of the document, the
docket number is corrected to read
‘‘FDA–2018–N–0410.’’
Dated: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04774 Filed 3–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–5946]
Determination That DORYX MPC
(Doxycycline Hyclate), DelayedRelease Tablets, 60 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
[FR Doc. 2018–04772 Filed 3–8–18; 8:45 am]
ACTION:
BILLING CODE 4164–01–P
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 milligrams (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 DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Aaron Young, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002, 301–
796–8083.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0410]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments;
Correction
AGENCY:
Food and Drug Administration,
amozie on DSK30RV082PROD with NOTICES
HHS.
Notice; establishment of a
public docket; request for comments;
correction.
ACTION:
The Food and Drug
Administration is correcting a notice
entitled ‘‘Peripheral and Central
Nervous System Drugs Advisory
SUMMARY:
VerDate Sep<11>2014
16:47 Mar 08, 2018
Jkt 244001
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
10493
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 (§ 314.162 (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.
DORYX MPC (doxycycline hyclate),
delayed-release tablets, 60 mg, are the
subject of NDA 50–795, held by Mayne
Pharma International Pty Ltd., and
initially approved on May 6, 2005.
DORYX MPC is indicated for rickettsial
infections; sexually transmitted
infections; respiratory tract infections;
specific bacterial infections; ophthalmic
infections; anthrax, including
inhalational anthrax (post-exposure);
alternative treatment for selected
infections when penicillin is
contraindicated; adjunctive therapy in
acute intestinal amebiasis and severe
acne; and prophylaxis of malaria.
Mayne Pharma International Pty Ltd.
has never marketed DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg. In previous instances
(see, e.g., 72 FR 9763 (March 5, 2007)
and 61 FR 25497 (May 21, 1996)), the
Agency has determined that, for
E:\FR\FM\09MRN1.SGM
09MRN1
10494
Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Goodwin Procter LLP submitted a
citizen petition dated September 26,
2017 (Docket No. FDA–2017–P–5946),
under 21 CFR 10.30, requesting that the
Agency determine whether DORYX
MPC (doxycycline hyclate), delayedrelease tablets, 60 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 DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that this drug
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of DORYX
MPC (doxycycline hyclate), delayedrelease tablets, 60 mg, from sale. We
have found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 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 this drug product
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: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04726 Filed 3–8–18; 8:45 am]
amozie on DSK30RV082PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:47 Mar 08, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Advisory Committee on
Interdisciplinary, Community-Based
Linkages
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meetings.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that two orientation
meetings are scheduled for the Advisory
Committee on Interdisciplinary,
Community-Based Linkages (ACICBL).
These meetings will be open to the
public. Information about the ACICBL
and the agenda for these meetings can
be obtained by accessing the ACICBL
website at: https://www.hrsa.gov/
advisory-committees/interdisciplinarycommunity-linkages/meetings/
index.html.
SUMMARY:
In order to accommodate the
schedules of the ACICBL members, two
orientation meetings will be held. The
first meeting will be on March 15, 2018
from 11:00 a.m.–4:00 p.m., ET and the
second meeting will be on March 27,
2018 from 12:00 p.m.–5:00 p.m., ET.
ADDRESSES: These meetings will be held
via conference call/webinar.
• The teleconference call-in number
is 1–800–619–2521, passcode: 9271697.
• The webinar link is https://
hrsa.connectsolutions.com/acicbl.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the ACICBL should contact
Joan Weiss, Ph.D., RN, CRNP, FAAN,
HRSA, in one of three ways: (1) Send a
request to the following address: Joan
Weiss, Ph.D., RN, CRNP, FAAN, Senior
Advisor and Designated Federal Officer,
Division of Medicine and Dentistry,
HRSA, 5600 Fishers Lane, Room 15N39,
Rockville, Maryland 20857; (2) call
(301) 443–0430; or (3) send an email to
jweiss@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
ACICBL provides advice and
recommendations on a broad range of
issues relating to grant programs
authorized by sections 750–760, Title
VII, Part D of the Public Health Service
Act. During the March 15, 2018 and
March 27, 2018 meetings. ACICBL
members will be oriented to the work of
the Committee and identify potential
topics to work on for 2018.
The ACICBL’s reports are submitted
to the Secretary of HHS; the Committee
DATES:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
on Health, Education, Labor, and
Pensions of the U.S. Senate; and the
Committee on Energy and Commerce of
the U.S. House of Representatives.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to the ACICBL should be sent by March
13, 2018 for the March 15, 2018 meeting
and by March 25, 2018 for the March 27,
2018 meeting.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–04815 Filed 3–8–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Pediatric Early Phase Clinical Trials Network
(PEP–CTN).
Date: March 27, 2018.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
7W538, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Shamala K. Srinivas,
Ph.D., Scientific Review Officer, Office of
Referral, Review, and Program Coordination,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W530, Bethesda, MD 20892–
9750, 240–276–6430, ss537t@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; U01 SEP:
Liquid Biopsy & Early Cancer Assessment.
Date: May 1, 2018.
Time: 10:00 a.m. to 5:00 p.m.
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10493-10494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-5946]
Determination That DORYX MPC (Doxycycline Hyclate), Delayed-
Release Tablets, 60 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 DORYX MPC (doxycycline hyclate), delayed-release
tablets, 60 milligrams (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 DORYX MPC
(doxycycline hyclate), delayed-release tablets, 60 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Aaron Young, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-8083.
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
(Sec. 314.162 (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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg,
are the subject of NDA 50-795, held by Mayne Pharma International Pty
Ltd., and initially approved on May 6, 2005. DORYX MPC is indicated for
rickettsial infections; sexually transmitted infections; respiratory
tract infections; specific bacterial infections; ophthalmic infections;
anthrax, including inhalational anthrax (post-exposure); alternative
treatment for selected infections when penicillin is contraindicated;
adjunctive therapy in acute intestinal amebiasis and severe acne; and
prophylaxis of malaria.
Mayne Pharma International Pty Ltd. has never marketed DORYX MPC
(doxycycline hyclate), delayed-release tablets, 60 mg. In previous
instances (see, e.g., 72 FR 9763 (March 5, 2007) and 61 FR 25497 (May
21, 1996)), the Agency has determined that, for
[[Page 10494]]
purposes of Sec. Sec. 314.161 and 314.162, never marketing an approved
drug product is equivalent to withdrawing the drug from sale.
Goodwin Procter LLP submitted a citizen petition dated September
26, 2017 (Docket No. FDA-2017-P-5946), under 21 CFR 10.30, requesting
that the Agency determine whether DORYX MPC (doxycycline hyclate),
delayed-release tablets, 60 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 DORYX MPC (doxycycline hyclate), delayed-
release tablets, 60 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DORYX MPC (doxycycline hyclate),
delayed-release tablets, 60 mg, from sale. We have found no information
that would indicate that this drug product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DORYX MPC
(doxycycline hyclate), delayed-release tablets, 60 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 this drug product 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: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04726 Filed 3-8-18; 8:45 am]
BILLING CODE 4164-01-P
