Determination That NUVIGIL (Armodafinil) Tablets, 100 Milligrams and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 44012-44013 [2011-18473]
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Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
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mstockstill on DSK4VPTVN1PROD with NOTICES
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17:59 Jul 21, 2011
Jkt 223001
transport, storage, set-up, safety, or
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(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: July 18, 2011.
Patrick Conway,
CMS Chief Medical Officer and Director,
Office of Clinical Standards and Quality,
Centers for Medicare & Medicaid Services.
[FR Doc. 2011–18562 Filed 7–21–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–P–0577 and FDA–
2010–P–0579]
Determination That NUVIGIL
(Armodafinil) Tablets, 100 Milligrams
and 200 Milligrams, 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Withdrawn From Sale for Reasons of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) has determined
that NUVIGIL (armodafinil) Tablets, 100
milligrams (mg) and 200 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for armodafinil
tablets, 100 mg and 200 mg, if all other
legal and regulatory requirements are
met.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Molly Flannery, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237,
Silver Spring, MD 20993–0002, 301–
796–3543.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
(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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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.
NUVIGIL (armodafinil) Tablets, 100
mg and 200 mg, are the subject of NDA
21–875, held by Cephalon, Inc., and
initially approved on June 15, 2007.
NUVIGIL is indicated to improve
wakefulness in patients with excessive
sleepiness associated with obstructive
sleep apnea, narcolepsy, and shift work
disorder.
NUVIGIL (armodafinil) Tablets, 100
mg and 200 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Actavis, Inc., submitted a citizen
petition dated November 9, 2010
(Docket No. FDA–2010–P–0579), under
21 CFR 10.30, requesting that the
Agency determine that NUVIGIL
(armodafinil) Tablets, 100 mg and 200
mg, were not voluntarily withdrawn for
safety or efficacy reasons. Watson
Laboratories, Inc., also submitted a
E:\FR\FM\22JYN1.SGM
22JYN1
Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
citizen petition dated November 9, 2010
(Docket No. FDA–2010–P–0577), under
21 CFR 10.30, requesting that the
Agency determine whether NUVIGIL
(armodafinil) Tablets, 100 mg and 200
mg, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records, FDA has
determined under 314.161 that
NUVIGIL (armodafinil) Tablets, 100 mg
and 200 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioners have identified no data or
other information suggesting that
NUVIGIL (armodafinil) Tablets, 100 mg
and 200 mg, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
NUVIGIL (armodafinil) Tablets, 100 mg
and 200 mg, 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 product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NUVIGIL (armodafinil)
Tablets, 100 mg and 200 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to NUVIGIL (armodafinil) Tablets, 100
mg and 200 mg, may 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: July 18 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–18473 Filed 7–21–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0487]
Draft Guidance for Industry:
Implementation of Acceptable FullLength and Abbreviated Donor History
Questionnaires and Accompanying
Materials for Use in Screening Donors
of Source Plasma; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Implementation
of Acceptable Full-Length and
Abbreviated Donor History
Questionnaires and Accompanying
Materials for Use in Screening Donors of
Source Plasma’’ dated July 2011. The
draft guidance document recognizes the
standardized full-length and abbreviated
donor history questionnaires and
accompanying materials, version 1.0.1
dated December 2010, as an acceptable
mechanism that is consistent with
FDA’s requirements and
recommendations for collecting Source
Plasma donor history information. The
Plasma Protein Therapeutics
Association (PPTA) Source Plasma
donor history questionnaires and
accompanying materials (SPDHQ
documents) will provide blood
establishments that collect Source
Plasma with a specific process for
administering questions to Source
Plasma donors to determine their
eligibility to donate.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 20,
2011.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
ADDRESSES:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
44013
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Implementation of Acceptable
Full-Length and Abbreviated Donor
History Questionnaires and
Accompanying Materials for Use in
Screening Donors of Source Plasma’’
dated July 2011. The draft guidance
document recognizes the standardized
full-length and abbreviated donor
history questionnaires and
accompanying materials, version 1.0.1
dated December 2010, prepared by the
PPTA, as an acceptable mechanism that
is consistent with FDA’s requirements
and recommendations for collecting
Source Plasma donor history
information. The SPDHQ documents
will provide blood establishments that
collect Source Plasma with a specific
process for administering questions to
Source Plasma donors to determine
their eligibility to donate. The guidance
also advises Source Plasma
manufacturers who choose to
implement the acceptable SPDHQ
documents on how to report the
manufacturing change consisting of the
implementation of the SPDHQ under 21
CFR 601.12.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44012-44013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-P-0577 and FDA-2010-P-0579]
Determination That NUVIGIL (Armodafinil) Tablets, 100 Milligrams
and 200 Milligrams, 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) has determined that
NUVIGIL (armodafinil) Tablets, 100 milligrams (mg) and 200 mg, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for armodafinil tablets, 100 mg and 200 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.
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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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.
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, are the subject
of NDA 21-875, held by Cephalon, Inc., and initially approved on June
15, 2007. NUVIGIL is indicated to improve wakefulness in patients with
excessive sleepiness associated with obstructive sleep apnea,
narcolepsy, and shift work disorder.
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Actavis, Inc., submitted a citizen petition dated November 9, 2010
(Docket No. FDA-2010-P-0579), under 21 CFR 10.30, requesting that the
Agency determine that NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg,
were not voluntarily withdrawn for safety or efficacy reasons. Watson
Laboratories, Inc., also submitted a
[[Page 44013]]
citizen petition dated November 9, 2010 (Docket No. FDA-2010-P-0577),
under 21 CFR 10.30, requesting that the Agency determine whether
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, were withdrawn from
sale for reasons of safety or effectiveness.
After considering the citizen petitions and reviewing Agency
records, FDA has determined under 314.161 that NUVIGIL (armodafinil)
Tablets, 100 mg and 200 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioners have identified no data or other
information suggesting that NUVIGIL (armodafinil) Tablets, 100 mg and
200 mg, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
NUVIGIL (armodafinil) Tablets, 100 mg and 200 mg, 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 product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list NUVIGIL (armodafinil)
Tablets, 100 mg and 200 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to NUVIGIL (armodafinil) Tablets, 100
mg and 200 mg, may 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: July 18 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18473 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P
