Determination That CEDAX (Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 16599-16600 [2017-06701]
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Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Food and Drug Administration/Xavier
University Medical Device Conference
(MedCon)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in co-sponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University Medical Device Conference
(MedCon).’’ This 3-day public
conference includes presentations from
key FDA officials and industry experts
with small group break-out sessions.
The conference is intended for
companies of all sizes and employees at
all levels.
DATES: The public conference will be
held on May 3, 2017, from 8:30 a.m. to
5 p.m.; May 4, 2017, from 8:30 a.m. to
5 p.m.; and May 5, 2017, from 8:30 a.m.
to 12:30 p.m.
ADDRESSES: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3016.
FOR FURTHER INFORMATION CONTACT:
For information regarding this notice:
Gina Brackett, Food and Drug
Administration, 6751 Steger Dr.,
Cincinnati, OH 45237, 513–679–2700,
FAX: 513–679–2771, email:
gina.brackett@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier Health, Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207–5471, 513–745–
3073, email: phillipsm4@xavier.edu or
visit https://www.XavierMedCon.com.
SUPPLEMENTARY INFORMATION: The
public conference helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
conference will provide those engaged
in FDA-regulated medical devices (for
humans) with information on the
following topics:
• Center Director Corner: Strategic
Priorities for 2017 and Beyond.
• European Union (EU) Regulations—
Exploring the Unknown.
• Impact of the New EU Regulations
on Your Global Regulatory Strategy.
• Digital Health—Key Focus Areas for
FDA and Industry.
• Office of Compliance Strategic
Priorities.
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SUMMARY:
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• Update from the Office of Device
Evaluation.
• FDA Insight on the 510(k)
Modifications Guidance.
• 510(k) Modifications: To submit or
not to submit?
• Your Contract Manufacturer
Received a Warning Letter. What Now?
• Defending Claims for Your Device.
• The Impact of Cultural
Misalignment . . . . and the Path
Forward.
• The Importance of Quality and
Regulatory throughout the Merger and
Acquisition Lifecycle—Landmines or
Opportunities.
• What to Expect with FDA’s Program
Alignment?
• Investigator Insights and Breaking
News.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, and lunches for the 3 days of
the conference. There will be onsite
registration. The cost of registration is as
follows:
TABLE 1—REGISTRATION FEES1
16599
To register by mail, please send your
name, title, firm name, address,
telephone, email, and payment
information for the fee to Xavier
University, Attention: Marla Phillips,
3800 Victory Pkwy., Cincinnati, OH
45207–5471. An email will be sent
confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarter hotel is the Downtown
Cincinnati Hilton Netherlands Plaza, 35
West 5th St., Cincinnati, OH, 45202,
513–421–9100. Special Conference
Block rates are available through April
11, 2017. To make reservations online,
please visit the ‘‘Venue/Logistics’’ link
at https://www.XavierMedCon.com. If
you need special accommodations due
to a disability, please contact Marla
Phillips (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the conference.
Dated: March 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–06699 Filed 4–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–3560]
Determination That CEDAX (Ceftibuten
Dihydrate) for Oral Suspension, 90
Milligrams/5 Milliliters and 180
Milligrams/5 Milliliters, 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 CEDAX (ceftibuten
Industry .........................................
1,695 dihydrate) for oral suspension, 90
Small Business (<100 employees)
1,200 milligrams (mg)/5 milliliters (mL) and
Start-up Manufacturer ...................
$300 180 mg/5 mL, were not withdrawn from
Academic ......................................
$300 sale for reasons of safety or
FDA/Government Employee .........
Free effectiveness. This determination will
1 The following forms of payment will be acallow FDA to approve abbreviated new
cepted: American Express, Visa, MasterCard, drug applications (ANDAs) for
and company checks.
ceftibuten dihydrate for oral suspension,
90 mg/5 mL and 180 mg/5 mL, if all
To register online for the public
other legal and regulatory requirements
conference, please visit the
are met.
‘‘Registration’’ link on the conference
Web site at https://
FOR FURTHER INFORMATION CONTACT:
www.XavierMedCon.com. FDA has
Anuj Shah, Center for Drug Evaluation
verified the Web site address, but is not
and Research, Food and Drug
responsible for subsequent changes to
Administration, 10903 New Hampshire
the Web site after this document
Ave., Bldg. 51, Rm. 6228, Silver Spring,
publishes in the Federal Register.
MD 20993–0002, 301–796–2246.
PO 00000
Standard
rate
Attendee type
Frm 00030
Fmt 4703
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SUMMARY:
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16600
Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
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.
CEDAX (ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, are the subject of NDA 050686, held
by Pernix Therapeutics LLC, and
initially approved on December 20,
1995. CEDAX is indicated for the
treatment of individuals with mild-tomoderate infections caused by
susceptible strains of Haemophilus
influenzae (including b-lactamaseproducing strains), Moraxella
catarrhalis (including b-lactamaseproducing strains), or Streptococcus
pneumoniae (penicillin-susceptible
strains only) in acute bacterial
exacerbations of chronic bronchitis; H.
influenzae (including b-lactamaseproducing strains), M. catarrhalis
(including b-lactamase-producing
strains), or S. pneumoniae (penicillinsusceptible strains only) in acute
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SUPPLEMENTARY INFORMATION:
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15:11 Apr 04, 2017
Jkt 241001
bacterial otitis media; and S. pyogenes
in pharyngitis and tonsillitis.
CEDAX (ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Orchid Healthcare (a division of
Orchid Pharma, Ltd.) submitted a
citizen petition dated October 26, 2016
(Docket No. FDA–2016–P–3560), under
21 CFR 10.30, requesting that the
Agency determine whether CEDAX
(ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, were 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 CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5
mL and 180 mg/5 mL, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that these drug products
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of CEDAX
(ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5
mL and 180 mg/5 mL, 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 these drug products 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 these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: March 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–06701 Filed 4–4–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for
Biomedical Imaging and Bioengineering.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Biomedical Imaging and
Bioengineering.
Date: May 18, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Report from the Institute Director,
other Institute Staff and scientific
presentation.
Place: The William F. Bolger Center,
Franklin Building, Classroom 1, 9600
Newbridge Drive, Potomac, MD 20854.
Closed: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: The William F. Bolger Center,
Franklin Building, Classroom 1, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: David T. George, Ph.D.,
Acting Associate Director, Office of Research
Administration, National Institute of
Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 920,
Bethesda, MD 20892.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nibib1.nih.gov/about/NACBIB/
E:\FR\FM\05APN1.SGM
05APN1
Agencies
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16599-16600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06701]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-3560]
Determination That CEDAX (Ceftibuten Dihydrate) for Oral
Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5
Milliliters, 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 CEDAX (ceftibuten dihydrate) for oral suspension, 90
milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL,
if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Anuj Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-796-2246.
[[Page 16600]]
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.
CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and
180 mg/5 mL, are the subject of NDA 050686, held by Pernix Therapeutics
LLC, and initially approved on December 20, 1995. CEDAX is indicated
for the treatment of individuals with mild-to-moderate infections
caused by susceptible strains of Haemophilus influenzae (including
[beta]-lactamase-producing strains), Moraxella catarrhalis (including
[beta]-lactamase-producing strains), or Streptococcus pneumoniae
(penicillin-susceptible strains only) in acute bacterial exacerbations
of chronic bronchitis; H. influenzae (including [beta]-lactamase-
producing strains), M. catarrhalis (including [beta]-lactamase-
producing strains), or S. pneumoniae (penicillin-susceptible strains
only) in acute bacterial otitis media; and S. pyogenes in pharyngitis
and tonsillitis.
CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and
180 mg/5 mL, are currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
Orchid Healthcare (a division of Orchid Pharma, Ltd.) submitted a
citizen petition dated October 26, 2016 (Docket No. FDA-2016-P-3560),
under 21 CFR 10.30, requesting that the Agency determine whether CEDAX
(ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL,
were 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 CEDAX (ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5 mL, were not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that these drug products were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that these drug products were not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, 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 these drug products
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 these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: March 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06701 Filed 4-4-17; 8:45 am]
BILLING CODE 4164-01-P