Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 52048 [2015-21236]
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52048
Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0002]
Determination That BIAXIN XL Oral
Tablets Were Not Withdrawn From Sale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) has determined
that the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 51, Rm. 6207, Silver Spring,
MD 20993–0002, 301–796–8363.
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 approved
under an ANDA procedure. ANDA
sponsors 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. Sponsors of
ANDAs 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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is 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was withdrawn from sale for reasons of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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Drug
Applicant
NDA 050775 ........................
rmajette on DSK2VPTVN1PROD with NOTICES
Application No.
BIAXIN XL Tablet; Oral 500 mg .....................................
AbbVie Inc., 1 North Waukegan Road, North Chicago,
IL 60064
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed in this
document are unaffected by the
discontinued marketing of the products
subject to those NDAs and ANDAs.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. 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.
VerDate Sep<11>2014
15:08 Aug 26, 2015
Jkt 235001
Dated: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–21236 Filed 8–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIA.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
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with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE ON AGING,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIA.
Date: October 13, 2015.
Closed: 7:30 a.m. to 7:45 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 3rd Floor
Conference Room, 251 Bayview Boulevard,
Baltimore, MD 21224.
Open: 7:45 a.m. to 11:30 a.m.
Agenda: Committee discussion, individual
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Place: National Institute on Aging,
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Baltimore, MD 21224.
Closed: 11:30 a.m. to 1:00 p.m.
E:\FR\FM\27AUN1.SGM
27AUN1
Agencies
[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Page 52048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21236]
[[Page 52048]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0002]
Determination That BIAXIN XL Oral Tablets 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) has determined that the
drug products listed in this document were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363.
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 approved under an ANDA procedure. ANDA
sponsors 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. Sponsors of ANDAs 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 generally known as the ``Orange
Book.'' Under FDA regulations, a drug is 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 050775.................. BIAXIN XL Tablet; AbbVie Inc., 1 North
Oral 500 mg. Waukegan Road,
North Chicago, IL
60064
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. 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: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21236 Filed 8-26-15; 8:45 am]
BILLING CODE 4164-01-P