Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug Application, 71135 [2010-29348]
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
Contact Person: Suzan Nadi, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
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Group; Biomaterials and Biointerfaces Study
Section.
Date: January 5–6, 2011.
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Agenda: To review and evaluate grant
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Avenue, Bethesda, MD 20814.
Contact Person: Steven J Zullo, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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93.337, 93.393–93.396, 93.837–93.844,
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Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29361 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0586]
Hoffmann-La Roche Inc.; Withdrawal of
Approval of a New Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for ACCUTANE (isotretinoin)
Capsules held by Hoffmann-La Roche
Inc., 340 Kingsland St., Nutley, NJ
07110–1199. Hoffmann-La Roche Inc.
notified the Agency in writing that the
drug product was no longer marketed
and requested that the approval of the
application be withdrawn.
DATES: Effective Date: November 22,
2010.
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SUMMARY:
HoffmannLa Roche Inc. has requested that FDA
withdraw approval of NDA 18–662,
ACCUTANE (isotretinoin) Capsules,
under the process in § 314.150(c) (21
CFR 314.150(c)), stating that the drug
product is no longer marketed.
Hoffmann-La Roche Inc. has also, by its
request, waived its opportunity for a
hearing. Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of NDA 18–662,
ACCUTANE (isotretinoin) Capsules, and
all amendments and supplements
thereto, is hereby withdrawn, effective
November 22, 2010. Introduction or
delivery for introduction into interstate
commerce of a product without an
approved application violates sections
301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). ACCUTANE
(isotretinoin) Capsules that are in
inventory on the date that this notice
becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug product has reached its
expiration date or otherwise become
violative, whichever occurs first.
In the Federal Register of July 7, 2010
(75 FR 39024), FDA issued a notice
announcing its determination that
ACCUTANE (isotretinoin) Capsules
were not withdrawn from sale for
reasons of safety or effectiveness, and
isotretinoin continues to be marketed
under approved abbreviated new drug
applications (ANDAs). The holders of
ANDAs for isotretinoin are subject to an
approved risk evaluation and mitigation
strategy (REMS) under section 505–1 of
the FD&C Act (21 U.S.C. 355–1), and the
REMS, known as the iPLEDGE program,
remains in effect.
SUPPLEMENTARY INFORMATION:
Dated: November 2, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2010–29348 Filed 11–19–10; 8:45 am]
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ADVISORY COUNCIL ON HISTORIC
PRESERVATION
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
VerDate Mar<15>2010
17:49 Nov 19, 2010
Jkt 223001
Notice of Meeting; Advisory Council on
Historic Preservation
Advisory Council on Historic
Preservation.
ACTION: Notice of meeting.
AGENCY:
PO 00000
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71135
Notice is hereby given that
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DC at 9 a.m.
The ACHP was established by the
National Historic Preservation Act of
1966 (16 U.S.C. 470 et seq.) to advise the
President and Congress on national
historic preservation policy and to
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assisted, and federally licensed
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properties listed in or eligible for
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of the National Trust for Historic
Preservation; the President of the
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SUMMARY:
Call to Order—9 a.m.
I. Chairman’s Welcome
II. Chairman’s Report
III. Executive Director’s Report
IV. Native American Activities
A. Native American Program Report
1. HUD Delegation of Tribal
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2. DOI–DoD–ACHP Memorandum of
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B. Native American Advisory Group
V. Strategic Planning: Next Steps
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A. Historic Preservation and Energy
Development Working Group
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X. New Business
XI. Adjourn
Note: The meetings of the ACHP are open
to the public.
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[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0586]
Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug
Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules
held by Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110-
1199. Hoffmann-La Roche Inc. notified the Agency in writing that the
drug product was no longer marketed and requested that the approval of
the application be withdrawn.
DATES: Effective Date: November 22, 2010.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche Inc. has requested that
FDA withdraw approval of NDA 18-662, ACCUTANE (isotretinoin) Capsules,
under the process in Sec. 314.150(c) (21 CFR 314.150(c)), stating that
the drug product is no longer marketed. Hoffmann-La Roche Inc. has
also, by its request, waived its opportunity for a hearing. Withdrawal
of approval of an application under Sec. 314.150(c) is without
prejudice to refiling.
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner of Food and Drugs, approval of NDA 18-662, ACCUTANE
(isotretinoin) Capsules, and all amendments and supplements thereto, is
hereby withdrawn, effective November 22, 2010. Introduction or delivery
for introduction into interstate commerce of a product without an
approved application violates sections 301(a) and (d) of the FD&C Act
(21 U.S.C. 331(a) and (d)). ACCUTANE (isotretinoin) Capsules that are
in inventory on the date that this notice becomes effective (see the
DATES section) may continue to be dispensed until the inventories have
been depleted or the drug product has reached its expiration date or
otherwise become violative, whichever occurs first.
In the Federal Register of July 7, 2010 (75 FR 39024), FDA issued a
notice announcing its determination that ACCUTANE (isotretinoin)
Capsules were not withdrawn from sale for reasons of safety or
effectiveness, and isotretinoin continues to be marketed under approved
abbreviated new drug applications (ANDAs). The holders of ANDAs for
isotretinoin are subject to an approved risk evaluation and mitigation
strategy (REMS) under section 505-1 of the FD&C Act (21 U.S.C. 355-1),
and the REMS, known as the iPLEDGE program, remains in effect.
Dated: November 2, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-29348 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P
