80 FR 52048 - Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 166 (August 27, 2015)

Page Range		52048-52048
FR Document		2015-21236

The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

Federal Register, Volume 80 Issue 166 (Thursday, August 27, 2015)

[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Page 52048]
From the Federal Register Online  [www.thefederalregister.org]
[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Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From 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.

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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drug products listed in this document were not withdrawn from sale for 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

52048 Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Notices

DEPARTMENT OF HEALTH AND Administration, 10903 New Hampshire ‘‘Orange Book.’’ Under FDA regulations,
HUMAN SERVICES Ave. Bldg. 51, Rm. 6207, Silver Spring, a drug is removed from the list if the
MD 20993–0002, 301–796–8363. Agency withdraws or suspends
Food and Drug Administration SUPPLEMENTARY INFORMATION: In 1984, approval of the drug’s NDA or ANDA
[Docket No. FDA–2015–N–0002] Congress enacted the Drug Price for reasons of safety or effectiveness, or
Competition and Patent Term if FDA determines that the listed drug
Determination That BIAXIN XL Oral Restoration Act of 1984 (Pub. L. 98–417) was withdrawn from sale for reasons of
Tablets Were Not Withdrawn From Sale (the 1984 amendments), which safety or effectiveness (21 CFR 314.162).
for Reasons of Safety or Effectiveness authorized the approval of duplicate Under § 314.161(a) (21 CFR
versions of drug products approved 314.161(a)), the Agency must determine
AGENCY: Food and Drug Administration, under an ANDA procedure. ANDA
HHS. whether a listed drug was withdrawn
sponsors must, with certain exceptions, from sale for reasons of safety or
ACTION: Notice. show that the drug for which they are effectiveness: (1) Before an ANDA that
seeking approval contains the same refers to that listed drug may be
SUMMARY: The Food and Drug
active ingredient in the same strength
Administration (FDA) has determined approved, (2) whenever a listed drug is
and dosage form as the ‘‘listed drug,’’
that the drug products listed in this voluntarily withdrawn from sale and
which is a version of the drug that was
document were not withdrawn from ANDAs that refer to the listed drug have
previously approved. Sponsors of
sale for reasons of safety or been approved, and (3) when a person
ANDAs do not have to repeat the
effectiveness. This determination means petitions for such a determination under
extensive clinical testing otherwise
that FDA will not begin procedures to necessary to gain approval of a new 21 CFR 10.25(a) and 10.30. Section
withdraw approval of abbreviated new drug application (NDA). 314.161(d) provides that if FDA
drug applications (ANDAs) that refer to The 1984 amendments include what determines that a listed drug was
these drug products, and it will allow is now section 505(j)(7) of the Federal withdrawn from sale for safety or
FDA to continue to approve ANDAs that Food, Drug, and Cosmetic Act (21 U.S.C. effectiveness reasons, the Agency will
refer to the products as long as they 355(j)(7)), which requires FDA to initiate proceedings that could result in
meet relevant legal and regulatory publish a list of all approved drugs. the withdrawal of approval of the
requirements. FDA publishes this list as part of the ANDAs that refer to the listed drug.
FOR FURTHER INFORMATION CONTACT: ‘‘Approved Drug Products With FDA has become aware that the drug
Stacy Kane, Center for Drug Evaluation Therapeutic Equivalence Evaluations,’’ products listed in the table in this
and Research, Food and Drug which is generally known as the document are no longer being marketed.

Application No. Drug Applicant

NDA 050775 ........................ BIAXIN XL Tablet; Oral 500 mg ..................................... AbbVie Inc., 1 North Waukegan Road, North Chicago,
IL 60064

FDA has reviewed its records and, Dated: August 21, 2015. with the provisions set forth in section
under § 314.161, has determined that Leslie Kux, 552b(c)(6), Title 5 U.S.C., as amended
the drug products listed in this Associate Commissioner for Policy. for the review, discussion, and
document were not withdrawn from [FR Doc. 2015–21236 Filed 8–26–15; 8:45 am] evaluation of individual intramural
sale for reasons of safety or BILLING CODE 4164–01–P
programs and projects conducted by the
effectiveness. Accordingly, the Agency NATIONAL INSTITUTE ON AGING,
will continue to list the drug products including consideration of personnel
listed in this document in the DEPARTMENT OF HEALTH AND qualifications and performance, and the
‘‘Discontinued Drug Product List’’ HUMAN SERVICES competence of individual investigators,
section of the Orange Book. The the disclosure of which would
National Institutes of Health constitute a clearly unwarranted
‘‘Discontinued Drug Product List’’
identifies, among other items, drug invasion of personal privacy.
National Institute on Aging; Notice of
products that have been discontinued Meeting Name of Committee: Board of Scientific
from marketing for reasons other than Counselors, NIA.
safety or effectiveness. Pursuant to section 10(d) of the Date: October 13, 2015.
Federal Advisory Committee Act, as Closed: 7:30 a.m. to 7:45 a.m.
Approved ANDAs that refer to the Agenda: To review and evaluate personal
amended (5 U.S.C. App.), notice is
NDAs and ANDAs listed in this qualifications and performance, and
hereby given of a meeting of the Board
document are unaffected by the of Scientific Counselors, NIA. competence of individual investigators.
discontinued marketing of the products Place: National Institute on Aging,
The meeting will be open to the
subject to those NDAs and ANDAs. public as indicated below, with Biomedical Research Center, 3rd Floor
Additional ANDAs that refer to these Conference Room, 251 Bayview Boulevard,
attendance limited to space available.
products may also be approved by the Baltimore, MD 21224.
Individuals who plan to attend and Open: 7:45 a.m. to 11:30 a.m.
rmajette on DSK2VPTVN1PROD with NOTICES

Agency if they comply with relevant need special assistance, such as sign
legal and regulatory requirements. If Agenda: Committee discussion, individual
language interpretation or other presentations, laboratory overview.
FDA determines that labeling for these reasonable accommodations, should Place: National Institute on Aging,
drug products should be revised to meet notify the Contact Person listed below Biomedical Research Center, 3rd Floor
current standards, the Agency will in advance of the meeting. Conference Room, 251 Bayview Boulevard,
advise ANDA applicants to submit such The meeting will be closed to the Baltimore, MD 21224.
labeling. public as indicated below in accordance Closed: 11:30 a.m. to 1:00 p.m.

VerDate Sep<11>2014 15:08 Aug 26, 2015 Jkt 235001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1

Document Created: 2015-12-15 10:53:03
Document Modified: 2015-12-15 10:53:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		80 FR 52048

80 FR 52048 - Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 166 (August 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration