80 FR 35959 - Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 120 (June 23, 2015)

Page Range		35959-35959
FR Document		2015-15327

The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Federal Register, Volume 80 Issue 120 (Tuesday, June 23, 2015)

[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Page 35959]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15327]



[[Page 35959]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0002]


Determination That ABILIFY (Aripiprazole) Solution 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 the drug product listed in this document was 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withdrawn from sale for reasons of safety or effectiveness.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 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product 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, 
Stacy.Kane@fda.hhs.gov.

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 
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 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 product listed in the table is 
no longer being marketed.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 021713..................  ABILIFY               Otsuka
                               (aripiprazole)        Pharmaceutical
                               Solution; Oral, 1     Development and
                               milligram/1           Commercialization
                               milliliter.           Inc., 2440 Research
                                                     Blvd., Rockville,
                                                     MD 20850.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug product listed in this document was not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the drug product 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 NDA listed in this document are 
unaffected by the discontinued marketing of the products subject to 
that NDA. Additional ANDAs that refer to this product may also be 
approved by the Agency if they comply with relevant legal and 
regulatory requirements. 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: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15327 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices 35959

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

Application No. Drug Applicant

NDA 021713 ........................ ABILIFY (aripiprazole) Solution; Oral, 1 milligram/1 milli- Otsuka Pharmaceutical Development and Commer-
liter. cialization Inc., 2440 Research Blvd., Rockville, MD
20850.

FDA has reviewed its records and, Dated: June 16, 2015. Date and Time: July 28, 2015, 3:00
under § 314.161, has determined that Leslie Kux, p.m.–4:00 p.m.
the drug product listed in this document Associate Commissioner for Policy. Place: This meeting is accessible via
was not withdrawn from sale for reasons [FR Doc. 2015–15327 Filed 6–22–15; 8:45 am] audio conference call and Adobe
of safety or effectiveness. Accordingly, BILLING CODE 4164–01–P
Connect Pro.
the Agency will continue to list the drug Status: This meeting is open to the
product listed in this document in the public. The virtual meeting is available
‘‘Discontinued Drug Product List’’ DEPARTMENT OF HEALTH AND via teleconference line and Adobe
section of the Orange Book. The HUMAN SERVICES Connect Pro Meeting and will
‘‘Discontinued Drug Product List’’ accommodate approximately 100
Health Resources and Services people. Join the meeting by:
identifies, among other items, drug
Administration 1. (Audio Portion) Calling the Toll-
products that have been discontinued
free Phone Number 1–800–369–3340
from marketing for reasons other than Centers for Disease Control and and providing the Public Participant
safety or effectiveness. Prevention (CDC)/Health Resources Pass Code 8527572; and
Approved ANDAs that refer to the and Services Administration (HRSA) 2. (Visual Portion) Connecting to the
NDA listed in this document are Advisory Committee on HIV, Viral Advisory Committee Adobe Connect Pro
unaffected by the discontinued Hepatitis and Sexually Transmitted Meeting using the following URL:
marketing of the products subject to that Diseases (STD) Prevention and https://hrsa.connectsolutions.com/cdc-
NDA. Additional ANDAs that refer to Treatment; Notice of Meeting hrsa_AC/. (Copy and paste the above
this product may also be approved by link into your browser if it does not
In accordance with section 10(a)(2) of
mstockstill on DSK4VPTVN1PROD with NOTICES

the Agency if they comply with relevant work directly). Participants should call
legal and regulatory requirements. If the Federal Advisory Committee Act and connect 15 minutes prior to the
FDA determines that labeling for this (Pub. L. 92–463), notice is hereby given meeting in order for logistics to be set
of the following meeting: up. Call (301) 443–9684 or send an
drug product should be revised to meet
current standards, the Agency will Name: CDC/HRSA Advisory email to sgordon@hrsa.gov if you have
advise ANDA applicants to submit such Committee on HIV, Viral Hepatitis and any questions, or send an email to
labeling. STD Prevention and Treatment CWilliams2@hrsa.gov if you are having
(CHACHSPT). trouble connecting to the meeting site.

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Document Created: 2018-02-22 11:15:06
Document Modified: 2018-02-22 11:15:06

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, [email protected]
FR Citation		80 FR 35959

80 FR 35959 - Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 120 (June 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration