Determination That LYMPHAZURIN (Isosulfan Blue) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 5560-5561 [2015-01859]
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Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
in the Federal Register of December 8,
2014. In the notice, FDA requested that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Food Advisory Committee
(the Committee) for the Center for Food
Safety and Applied Nutrition (CFSAN)
notify FDA in writing. FDA is also
requesting nominations for a nonvoting
industry representative(s) to serve on
the Committee. The Agency is taking
this action in response to requests for an
extension to allow interested persons
additional time to submit letters of
interests and nominations.
DATES: FDA is extending the closing
date in the notice published December
8, 2014 (79 FR 72690). Any industry
organization interested in participating
in the selection of an appropriate
nonvoting member to represent industry
interests must send a letter stating that
interest to FDA by February 27, 2015.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by February 27, 2015.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Karen
Strambler (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives may
be submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://www.
fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Karen Strambler, Office of Regulations,
Policy, and Social Science, Center for
Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., Rm. 1C–016,
College Park, MD 20740, 240–402–2589,
karen.strambler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
I. CFSAN Advisory Committee, Food
Advisory Committee
The Committee reviews and evaluates
emerging food safety, nutrition and
other food- or cosmetic-related health
issues that FDA considers of primary
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19:24 Jan 30, 2015
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importance for its food and cosmetics
programs. The Committee may be
charged with reviewing and evaluating
available data and making
recommendations on matters such as
those relating to: (1) Broad scientific and
technical food- or cosmetic-related
issues; (2) the safety of food ingredients
and new foods; (3) labeling of foods and
cosmetics; (4) nutrient needs and
nutritional adequacy; and (5) safe
exposure limits for food contaminants.
The Committee may also be asked to
provide advice and make
recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current curriculum vitae. The
letter will also state that it is the
responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
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FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01881 Filed 1–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0175]
Determination That LYMPHAZURIN
(Isosulfan Blue) Injectable and Other
Drug Products 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 or Agency) 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:
Amy Hopkins, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223,
Silver Spring, MD 20993–0002, 301–
796–5418, Amy.Hopkins@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
SUMMARY:
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02FEN1
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
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 § 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
5561
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.
(As requested by the applicants, FDA
withdrew approval of NDA 018310 for
LYMPHAZURIN (isosulfan blue)
Injectable in the Federal Register of
December 5, 2014 (79 FR 72186) and
NDA 020151 for EFFEXOR (venlafaxine
HCl) Tablets in the Federal Register of
July 19, 2013 (78 FR 43210).)
Application No.
Drug
Applicant
NDA 018310 .................
NDA 019966 .................
LYMPHAZURIN (isosulfan blue) Injectable; Injection, 1%
TEMOVATE (clobetasol propionate) Solution; Topical,
0.05%.
EFFEXOR (venlafaxine hydrochloride (HCl)) Tablet; Oral,
Equivalent to (EQ) 12.5 milligram (mg) Base; EQ 25
mg Base; EQ 37.5 mg Base; EQ 50 mg Base; EQ 75
mg Base; EQ 100 mg Base.
ZEMURON (rocuronium bromide) Injectable; Injection 100
mg/10 milliliter (mL); 50 mg/5 mL; 10 mg/mL.
PREFEST (estradiol; norgestimate) Tablet; Oral, 1 mg, 1
mg/0.09 mg.
CHILDREN’S ZYRTEC ALLERGY (cetirizine HCl) and
CHILDREN’S ZYRTEC HIVES RELIEF (cetirizine HCl)
Chewable Tablet; Oral, 5 mg; 10 mg.
PERIOSTAT (doxycycline hyclate) Tablet; Oral, EQ 20
mg Base.
Covidien, 60 Middletown Ave., North Haven, CT 06473.
Fougera Pharmaceuticals Inc., 1 Health Plaza, Bldg. 434,
East Hanover, NJ 07936.
Wyeth Pharmaceuticals Inc., 235 East 42nd St., New
York, NY 10017.
Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than March 4, 2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evaluation and Initial Assessment of the
HRSA Teaching Health Centers
Graduate Medical Education Program.
OMB No. 0906–xxxx—New.
Abstract: Section 5508 of the
Affordable Care Act of 2010 amended
section 340H of the Public Health
Service Act to establish the Teaching
Health Center Graduate Medical
Education (THCGME) program to
provide funding support for new and
NDA 020151 .................
NDA 020214 .................
NDA 021040 .................
NDA 021621 .................
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NDA 050783 .................
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 listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. 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.
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Organon USA Inc., 351 North Sunmeytown Pike, North
Wales, PA 19454.
Teva Branded Pharmaceutical Products R&D, Inc., 41
Moores Rd., P.O. Box 4011, Frazer, PA 19355.
McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort
Washington, PA 19034.
Galderma Laboratories, L.P., 14501 North Freeway, Fort
Worth, TX 76177.
[FR Doc. 2015–01859 Filed 1–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Pages 5560-5561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01859]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0175]
Determination That LYMPHAZURIN (Isosulfan Blue) Injectable and
Other Drug Products 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 or Agency) 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: Amy Hopkins, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, Amy.Hopkins@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
[[Page 5561]]
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 products listed in the table in
this document are no longer being marketed. (As requested by the
applicants, FDA withdrew approval of NDA 018310 for LYMPHAZURIN
(isosulfan blue) Injectable in the Federal Register of December 5, 2014
(79 FR 72186) and NDA 020151 for EFFEXOR (venlafaxine HCl) Tablets in
the Federal Register of July 19, 2013 (78 FR 43210).)
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 018310.................. LYMPHAZURIN Covidien, 60
(isosulfan blue) Middletown Ave.,
Injectable; North Haven, CT
Injection, 1%. 06473.
NDA 019966.................. TEMOVATE (clobetasol Fougera
propionate) Pharmaceuticals
Solution; Topical, Inc., 1 Health
0.05%. Plaza, Bldg. 434,
East Hanover, NJ
07936.
NDA 020151.................. EFFEXOR (venlafaxine Wyeth
hydrochloride Pharmaceuticals
(HCl)) Tablet; Inc., 235 East 42nd
Oral, Equivalent to St., New York, NY
(EQ) 12.5 milligram 10017.
(mg) Base; EQ 25 mg
Base; EQ 37.5 mg
Base; EQ 50 mg
Base; EQ 75 mg
Base; EQ 100 mg
Base.
NDA 020214.................. ZEMURON (rocuronium Organon USA Inc.,
bromide) 351 North
Injectable; Sunmeytown Pike,
Injection 100 mg/10 North Wales, PA
milliliter (mL); 50 19454.
mg/5 mL; 10 mg/mL.
NDA 021040.................. PREFEST (estradiol; Teva Branded
norgestimate) Pharmaceutical
Tablet; Oral, 1 mg, Products R&D, Inc.,
1 mg/0.09 mg. 41 Moores Rd., P.O.
Box 4011, Frazer,
PA 19355.
NDA 021621.................. CHILDREN'S ZYRTEC McNeil Consumer
ALLERGY (cetirizine Healthcare, 7050
HCl) and CHILDREN'S Camp Hill Rd., Fort
ZYRTEC HIVES RELIEF Washington, PA
(cetirizine HCl) 19034.
Chewable Tablet;
Oral, 5 mg; 10 mg.
NDA 050783.................. PERIOSTAT Galderma
(doxycycline Laboratories, L.P.,
hyclate) Tablet; 14501 North
Oral, EQ 20 mg Base. Freeway, Fort
Worth, TX 76177.
------------------------------------------------------------------------
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 listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. 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: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01859 Filed 1-30-15; 8:45 am]
BILLING CODE 4164-01-P
