Determination That ENJUVIA (Estrogens, Conjugated Synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 41967-41968 [2017-18693]
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Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
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transmit, and administratively
inefficient, as staff reviewing different
parts of the application are located in
different physical locations and must
receive hard copies of the material.
However, beginning in 2016 and 2017,
initial and SAE PACE applications,
respectively, are being submitted via a
new automated, electronic submission
process. As with initial applications, an
application also must be submitted for
a PO that seeks to expand its service
area and/or add a new service site, and
with OMB approval, an automated
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required of PACE organizations
submitting service area expansion
applications. The collection specific to
the application was approved by OMB
for a 3-year period, which expires
March 31, 2020. Approval is now
requested for revisions to this currentlyapproved collection, which includes
modifications to the PACE application.
Form Number: CMS–10631 (OMB
control number: 0938–1326); Frequency:
Once and occasionally; Affected Public:
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Dated: August 30, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–18738 Filed 9–1–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–1459]
Determination That ENJUVIA
(Estrogens, Conjugated Synthetic B)
Tablets, 0.625 Milligrams and 1.25
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
mstockstill on DSK30JT082PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
milligrams (mg) and 1.25 mg, were not
withdrawn from sale for reasons of
SUMMARY:
VerDate Sep<11>2014
17:43 Sep 01, 2017
Jkt 241001
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for ENJUVIA
(estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Bronwen Blass, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
796–5092.
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ENJUVIA (estrogens, conjugated
synthetic B) tablets, 0.625 mg and 1.25
mg, is the subject of NDA 021443, held
by Teva Branded Pharmaceutical
Products R&D, Inc. (Teva), and was
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
41967
initially approved on May 10, 2004.
ENJUVIA is indicated for treatment of
moderate to severe vasomotor symptoms
due to menopause and treatment of
moderate to severe vaginal dryness and
pain with intercourse, as well as
symptoms of vulvar and vaginal atrophy
due to menopause.
In 2016, Teva notified FDA that
ENJUVIA (estrogens, conjugated
synthetic B) tablets, 0.625 mg and 1.25
mg, were being discontinued, and FDA
moved those drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Foley & Lardner submitted a citizen
petition dated March 8, 2017 (Docket
No. FDA–2017–P–1459), under 21 CFR
10.30, requesting that the Agency
determine whether ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
mg and 1.25 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 ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
mg and 1.25 mg, were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that these
products were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of ENJUVIA
(estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 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 drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625
mg and 1.25 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 ENJUVIA
(estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 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 this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
E:\FR\FM\05SEN1.SGM
05SEN1
41968
Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18693 Filed 9–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–4282]
Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling.’’ This draft guidance is being
issued in accordance with the Food and
Drug Administration Safety and
Innovation Act (FDASIA), which
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to require
that certain submissions under the
FD&C Act and the Public Health Service
Act (PHS Act) be submitted in
electronic format, beginning no earlier
than 24 months after issuance of final
guidance on electronic format for
submissions. The draft guidance
describes how FDA plans to implement
the requirements for the electronic
submission of Risk Evaluation and
Mitigation Strategies (REMS) documents
in certain submissions under new drug
applications, abbreviated new drug
applications, and biologics license
applications, beginning no earlier than
24 months after issuance of the final
guidance.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by March 5, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
mstockstill on DSK30JT082PROD with NOTICES
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:43 Sep 01, 2017
Jkt 241001
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. [FDA–
2017–E–4282] for ’’ Providing
Regulatory Submissions in Electronic
Format—Content of the Risk Evaluation
and Mitigation Strategies Document
Using Structured Product Labeling;
Draft Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff office
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). 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, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Adam Kroetsch, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 51, Rm.
1168, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 301–
796–3842; or Aaron Sherman, Center for
Drug Evaluation and Research, Food
and Drug Administration, Bldg. 51, Rm.
E:\FR\FM\05SEN1.SGM
05SEN1
]]>Agencies
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41967-41968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-1459]
Determination That ENJUVIA (Estrogens, Conjugated Synthetic B)
Tablets, 0.625 Milligrams and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) tablets,
0.625 milligrams (mg) and 1.25 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 ENJUVIA
(estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-5092.
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and
1.25 mg, is the subject of NDA 021443, held by Teva Branded
Pharmaceutical Products R&D, Inc. (Teva), and was initially approved on
May 10, 2004. ENJUVIA is indicated for treatment of moderate to severe
vasomotor symptoms due to menopause and treatment of moderate to severe
vaginal dryness and pain with intercourse, as well as symptoms of
vulvar and vaginal atrophy due to menopause.
In 2016, Teva notified FDA that ENJUVIA (estrogens, conjugated
synthetic B) tablets, 0.625 mg and 1.25 mg, were being discontinued,
and FDA moved those drug products to the ``Discontinued Drug Product
List'' section of the Orange Book.
Foley & Lardner submitted a citizen petition dated March 8, 2017
(Docket No. FDA-2017-P-1459), under 21 CFR 10.30, requesting that the
Agency determine whether ENJUVIA (estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B)
tablets, 0.625 mg and 1.25 mg, were not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that these products were withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ENJUVIA (estrogens, conjugated
synthetic B) tablets, 0.625 mg and 1.25 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 drug products were withdrawn from sale for reasons
of safety or effectiveness.
Accordingly, the Agency will continue to list ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens,
conjugated synthetic B) tablets, 0.625 mg and 1.25 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 this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.
[[Page 41968]]
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18693 Filed 9-1-17; 8:45 am]
BILLING CODE 4164-01-P
