Determination That OVRETTE (Norgestrel) Tablet, 0.075 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 49380 [2017-23125]
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–0840]
Determination That OVRETTE
(Norgestrel) Tablet, 0.075 Milligrams,
Was Not Withdrawn From Sale for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 OVRETTE (norgestrel)
tablet, 0.075 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for norgestrel
tablet, 0.075 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002, 301–
796–6650.
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was withdrawn from sale for reasons of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).
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
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
FDA’s approval of 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.
OVRETTE (norgestrel) tablet, 0.075
mg, is the subject of NDA 017031, held
by HRA Pharma and initially approved
on October 23, 1973. OVRETTE is
indicated for the prevention of
pregnancy in women.
OVRETTE (norgestrel) tablet, 0.075
mg, was discontinued from U.S.
distribution on June 7, 2005, and is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
The Weinberg Group submitted a
citizen petition dated February 8, 2017
(Docket No. FDA–2017–P–0840), under
21 CFR 10.30, requesting that the
Agency determine whether OVRETTE
(norgestrel) tablet, 0.075 mg, was
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 OVRETTE (norgestrel)
tablet, 0.075 mg, was not withdrawn
from sale for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that OVRETTE (norgestrel)
tablet, 0.075 mg, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
OVRETTE (norgestrel) tablet, 0.075 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 this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list OVRETTE (norgestrel)
tablet, 0.075 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: October 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23125 Filed 10–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0656]
Animal Drug User Fee Act;
Recommendations; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments; extension of comment
period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the
Animal Drug User Fee Act (ADUFA)
reauthorization draft recommendations
and extending the comment period to
allow interested persons 30 days to
submit comments on these draft
recommendations.
DATES: FDA is extending the comment
period on the ADUFA reauthorization
and draft recommendations. Submit
either electronic or written comments
on the draft recommendations by
November 24, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 24,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end November 24, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• 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
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Page 49380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23125]
[[Page 49380]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-0840]
Determination That OVRETTE (Norgestrel) Tablet, 0.075 Milligrams,
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 or Agency) has
determined that OVRETTE (norgestrel) tablet, 0.075 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for norgestrel tablet, 0.075 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-6650.
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 FDA's approval of 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.
OVRETTE (norgestrel) tablet, 0.075 mg, is the subject of NDA
017031, held by HRA Pharma and initially approved on October 23, 1973.
OVRETTE is indicated for the prevention of pregnancy in women.
OVRETTE (norgestrel) tablet, 0.075 mg, was discontinued from U.S.
distribution on June 7, 2005, and is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
The Weinberg Group submitted a citizen petition dated February 8,
2017 (Docket No. FDA-2017-P-0840), under 21 CFR 10.30, requesting that
the Agency determine whether OVRETTE (norgestrel) tablet, 0.075 mg, was
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 OVRETTE (norgestrel) tablet, 0.075 mg, was not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
OVRETTE (norgestrel) tablet, 0.075 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of OVRETTE (norgestrel) tablet, 0.075
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 this drug product was withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list OVRETTE (norgestrel)
tablet, 0.075 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: October 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23125 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P
