Determination That MUTAMYCIN (Mitomycin) Injectable, 5 Milligrams/Vial and 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 27010-27011 [2018-12441]
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations. Members will be invited
to serve for overlapping terms of up to
4 years. Almost all non-Federal
members of this Committee serve as
Special Government Employees. The
core of voting members may include one
or more technically qualified members,
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one or more non-voting
members who are identified with
industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
PharmacyCompounding
AdvisoryCommittee/ucm381305.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12440 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2018–N–1725]
Advisory Committee; Peripheral and
Central Nervous System Drugs
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Peripheral and Central
Nervous System Drugs Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Peripheral and Central Nervous System
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until June 4, 2020.
DATES: Authority for the Peripheral and
Central Nervous System Drugs Advisory
Committee will expire on June 4, 2020,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Yinghua Wang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002; 301–
796–9001, email: PCNS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Peripheral and Central Nervous System
Drugs Advisory Committee. The
committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Peripheral and Central Nervous
System Drugs Advisory Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of neurologic
diseases.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
neurology, neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
SUMMARY:
PO 00000
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Fmt 4703
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voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
PeripheralandCentralNervousSystem
DrugsAdvisoryCommittee/default.htm
or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12443 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–0327]
Determination That MUTAMYCIN
(Mitomycin) Injectable, 5 Milligrams/
Vial and 20 Milligrams/Vial, 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 MUTAMYCIN
(mitomycin) injectable, 5 milligrams
(mg)/vial and 20 mg/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20
mg/vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
SUMMARY:
E:\FR\FM\11JNN1.SGM
11JNN1
Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
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.
MUTAMYCIN (mitomycin) injectable,
5 mg/vial and 20 mg/vial, is the subject
of NDA 050450, held by Bristol
Laboratories Inc., and initially approved
on May 28, 1974. MUTAMYCIN has
been shown to be useful in the therapy
of disseminated adenocarcinoma of the
stomach or pancreas in proven
combinations with other approved
chemotherapeutic agents and as
palliative treatment when other
modalities have failed. MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20
mg/vial, is currently listed in the
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Fresenius Kabi USA, LLC submitted a
citizen petition dated January 22, 2018
(Docket No. FDA–2018–P–0327), under
21 CFR 10.30, requesting that the
Agency determine whether
MUTAMYCIN (mitomycin) injectable, 5
mg/vial and 20 mg/vial, 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 MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20
mg/vial, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that this product
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
MUTAMYCIN (mitomycin) injectable, 5
mg/vial and 20 mg/vial, 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 MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20
mg/vial, 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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also 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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12441 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
27011
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1728]
Advisory Committee; Drug Safety and
Risk Management Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Drug Safety and Risk
Management Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Drug Safety and
Risk Management Advisory Committee
for an additional 2 years beyond the
charter expiration date. The new charter
will be in effect until May 31, 2020.
DATES: Authority for the Drug Safety
and Risk Management Advisory
Committee will expire on May 31, 2018,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Philip Bautista, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, DSaRM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Drug Safety and Risk Management
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Drug Safety and Risk
Management Advisory Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
information on risk management, risk
communication, and quantitative
evaluation of spontaneous reports for
drugs for human use and for any other
product for which FDA has regulatory
responsibility. The Committee also
advises the Commissioner regarding the
scientific and medical evaluation of all
SUMMARY:
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27010-27011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-0327]
Determination That MUTAMYCIN (Mitomycin) Injectable, 5
Milligrams/Vial and 20 Milligrams/Vial, 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 MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/
vial and 20 mg/vial, was not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for MUTAMYCIN (mitomycin)
injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
[[Page 27011]]
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[email protected].
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.
MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, is the
subject of NDA 050450, held by Bristol Laboratories Inc., and initially
approved on May 28, 1974. MUTAMYCIN has been shown to be useful in the
therapy of disseminated adenocarcinoma of the stomach or pancreas in
proven combinations with other approved chemotherapeutic agents and as
palliative treatment when other modalities have failed. MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20 mg/vial, is currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
Fresenius Kabi USA, LLC submitted a citizen petition dated January
22, 2018 (Docket No. FDA-2018-P-0327), under 21 CFR 10.30, requesting
that the Agency determine whether MUTAMYCIN (mitomycin) injectable, 5
mg/vial and 20 mg/vial, 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 MUTAMYCIN (mitomycin) injectable, 5 mg/vial
and 20 mg/vial, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this product was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of MUTAMYCIN (mitomycin) injectable,
5 mg/vial and 20 mg/vial, 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 MUTAMYCIN (mitomycin)
injectable, 5 mg/vial and 20 mg/vial, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12441 Filed 6-8-18; 8:45 am]
BILLING CODE 4164-01-P
