Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 Abbreviated New Drug Applications, 92821-92822 [2016-30623]
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Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH 278]
Request for Nominations of
Candidates To Serve on the Board of
Scientific Counselors (BSC), National
Institute for Occupational Safety and
Health (NIOSH)
The Centers for Disease Control and
Prevention (CDC) is soliciting
nominations for possible membership
on the BSC, NIOSH.
The BSC, NIOSH consists of 15
experts in fields related to occupational
safety and health. The members are
selected by the Secretary of the U.S.
Department of Health and Human
Services (HHS). The board advises the
NIOSH Director on occupational safety
and health research and prevention
programs. The board also provides
advice on standards of scientific
excellence, current needs in the field of
occupational safety and health, and the
applicability and dissemination of
research findings. This advice may take
the form of reports or verbal
communications to the NIOSH Director
during BSC meetings. Nominations are
being sought for individuals who have
expertise and qualifications necessary to
contribute to the accomplishment of the
board’s mission. More information is
available on the NIOSH BSC Web site:
https://www.cdc.gov/niosh/BSC/
default.html.
Nominees will be selected based on
expertise in occupational safety and
health fields, such as occupational
medicine, occupational nursing,
industrial hygiene, occupational safety
and health engineering, toxicology,
chemistry, safety and health education,
ergonomics, epidemiology, biostatistics,
and psychology. Members may be
invited to serve for terms of two to four
years. Selected nominees would begin
service on the BSC, NIOSH in January
2018.
The U.S. Department of Health and
Human Services policy stipulates that
committee membership shall be
balanced in terms of points of view
represented, and the committee’s
function. Appointments shall be made
without discrimination on the basis of
age, race, ethnicity, gender, sexual
orientation, gender identity, HIV status,
disability, and cultural, religious, or
socioeconomic status. Nominees must
be U.S. citizens, and cannot be full-time
employees of the U.S. Government or
federally registered lobbyists. Current
participation on federal workgroups or
prior experience serving on a federal
advisory committee does not disqualify
a candidate; however, HHS policy is to
avoid excessive individual service on
advisory committees and multiple
committee memberships. Board
members are Special Government
Employees, requiring the filing of
financial disclosure reports at the
beginning and annually during their
terms. CDC reviews potential candidates
for the Board membership each year,
and provides a slate of nominees for
consideration to the Secretary of HHS
for final selection.
Candidates should submit the
following items:
• Current curriculum vitae, including
complete contact information (name,
affiliation, mailing address, telephone
number, email address)
• A letter of recommendation stating
the qualifications of the candidate.
Nominations must be submitted
(postmarked or electronically received)
by January 31, 2017.
Submissions must be electronic or by
mail. Submissions should reference
docket 278. Electronic submissions: You
may electronically submit nominations,
including attachments, to nioshdocket@
cdc.gov.
Attachments in Microsoft Word are
preferred. Regular, Express, or
Overnight Mail: Written nominations
may be submitted (one original and two
copies) to the following address only:
NIOSH Docket 278, c/o Richie
Dickerson, Committee Management
Specialist, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
1600 Clifton Road NE., MS: E–20,
Atlanta, Georgia 30329. Telephone and
facsimile submissions cannot be
accepted.
The Director, Management Analysis
and Services Office, has been delegated
mstockstill on DSK3G9T082PROD with NOTICES
Application No.
065007
065016
065021
065059
065060
065081
065082
065083
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the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–30522 Filed 12–19–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4320]
Sun Pharmaceutical Industries, Inc.;
Withdrawal of Approval of 28
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 28 abbreviated new drug
applications held by Sun
Pharmaceutical Industries, Inc. (Sun
Pharmaceutical), U.S. Agent for Sun
Pharmaceutical Industries Limited, 270
Prospect Plains Rd., Cranbury, NJ
08512. The drug products are no longer
marketed, and Sun Pharmaceutical has
requested that the approval of the
applications be withdrawn.
DATES: January 19, 2017.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
applications listed in the table in this
document are no longer marketed, and
Sun Pharmaceutical has requested that
FDA withdraw approval of the
applications. The company has also, by
its request, waived its opportunity for a
hearing.
SUMMARY:
Drug
Cephalexin Capsules USP, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base.
Amoxicillin Capsules USP, 250 mg and 500 mg.
Amoxicillin Tablets USP (Chewable), 125 mg and 250 mg.
Amoxicillin Tablets USP, 500 mg and 875 mg.
Amoxicillin Tablets USP (Chewable), 200 mg and 400 mg.
Cephalexin for Oral Suspension USP, EQ 125 mg base/5 milliliters (mL) and EQ 250 mg base/5 mL.
Cefpodoxime Proxetil for Oral Suspension USP, EQ 50 mg base/5 mL and EQ 100 mg base/5 mL.
Cefpodoxime Proxetil Tablets USP, EQ 100 mg base and EQ 200 mg base.
19:36 Dec 19, 2016
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Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
Application No.
065102
065109
065113
065115
065118
065132
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065161 .......................
065207
065323
074975
074980
075132
075439
076041
076285
076332
076409
076503
076606
076739
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Drug
Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/EQ 125 mg base.
Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/EQ 125 mg base.
Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL.
Cefadroxil for Oral Suspension USP, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
Cefuroxime Axetil Tablets USP, EQ 125 mg base, EQ 250 mg base, and EQ 500 mg base.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/EQ 28.5 mg base per 5 mL and 400 mg/EQ
57 mg base per 5 mL.
Amoxicillin and Clavulanate Potassium Tablets USP (Chewable), 200 mg/EQ 28.5 mg base and 400 mg/EQ 57 mg
base.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/EQ 42.9 mg base per 5 mL.
Cefuroxime Axetil for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL.
Acyclovir Capsules USP, 200 mg.
Acyclovir Tablets USP, 400 mg and 800 mg.
Ranitidine Tablets USP, EQ 75 mg base.
Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base.
Sotret (isotretinoin) Capsules USP, 10 mg, 20 mg, and 40 mg.
Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg.
Fluconazole for Oral Suspension, 10 mg/mL and 40 mg/mL.
Nefazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg.
Sotret (isotretinoin) Capsules USP, 30 mg.
Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg.
Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for
Drug Evaluation and Research, by the
Commissioner, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn, effective January
19, 2017.
Dated: December 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30623 Filed 12–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0969]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Zika Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
detection of the Zika virus in response
to the Zika virus outbreak in the
Americas. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Abbott Molecular, Inc.
The Authorization contains, among
other things, conditions on the
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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19:36 Dec 19, 2016
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emergency use of the authorized in vitro
diagnostic device. The Authorization
follows the February 26, 2016,
determination by the Secretary of Health
and Human Services (HHS) that there is
a significant potential for a public
health emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves Zika
virus. On the basis of such
determination, the Secretary of HHS
declared on February 26, 2016, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostic tests for detection of
Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of
any authorization issued under the
FD&C Act. The Authorization, which
includes an explanation of the reasons
for issuance, is reprinted in this
document.
The Authorization is effective as
of November 21, 2016.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
DATES:
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
4347, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
E:\FR\FM\20DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92821-92822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30623]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4320]
Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 28 abbreviated new drug applications held by Sun Pharmaceutical
Industries, Inc. (Sun Pharmaceutical), U.S. Agent for Sun
Pharmaceutical Industries Limited, 270 Prospect Plains Rd., Cranbury,
NJ 08512. The drug products are no longer marketed, and Sun
Pharmaceutical has requested that the approval of the applications be
withdrawn.
DATES: January 19, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The applications listed in the table in this
document are no longer marketed, and Sun Pharmaceutical has requested
that FDA withdraw approval of the applications. The company has also,
by its request, waived its opportunity for a hearing.
------------------------------------------------------------------------
Application No. Drug
------------------------------------------------------------------------
065007........................... Cephalexin Capsules USP, Equivalent
to (EQ) 250 milligrams (mg) base and
EQ 500 mg base.
065016........................... Amoxicillin Capsules USP, 250 mg and
500 mg.
065021........................... Amoxicillin Tablets USP (Chewable),
125 mg and 250 mg.
065059........................... Amoxicillin Tablets USP, 500 mg and
875 mg.
065060........................... Amoxicillin Tablets USP (Chewable),
200 mg and 400 mg.
065081........................... Cephalexin for Oral Suspension USP,
EQ 125 mg base/5 milliliters (mL)
and EQ 250 mg base/5 mL.
065082........................... Cefpodoxime Proxetil for Oral
Suspension USP, EQ 50 mg base/5 mL
and EQ 100 mg base/5 mL.
065083........................... Cefpodoxime Proxetil Tablets USP, EQ
100 mg base and EQ 200 mg base.
[[Page 92822]]
065102........................... Amoxicillin and Clavulanate Potassium
Tablets USP, 875 mg/EQ 125 mg base.
065109........................... Amoxicillin and Clavulanate Potassium
Tablets USP, 500 mg/EQ 125 mg base.
065113........................... Amoxicillin for Oral Suspension USP,
200 mg/5 mL and 400 mg/5 mL.
065115........................... Cefadroxil for Oral Suspension USP,
EQ 125 mg base/5 mL, EQ 250 mg base/
5 mL, and EQ 500 mg base/5 mL.
065118........................... Cefuroxime Axetil Tablets USP, EQ 125
mg base, EQ 250 mg base, and EQ 500
mg base.
065132........................... Amoxicillin and Clavulanate Potassium
for Oral Suspension USP, 200 mg/EQ
28.5 mg base per 5 mL and 400 mg/EQ
57 mg base per 5 mL.
065161........................... Amoxicillin and Clavulanate Potassium
Tablets USP (Chewable), 200 mg/EQ
28.5 mg base and 400 mg/EQ 57 mg
base.
065207........................... Amoxicillin and Clavulanate Potassium
for Oral Suspension USP, 600 mg/EQ
42.9 mg base per 5 mL.
065323........................... Cefuroxime Axetil for Oral Suspension
USP, EQ 125 mg base/5 mL and EQ 250
mg base/5 mL.
074975........................... Acyclovir Capsules USP, 200 mg.
074980........................... Acyclovir Tablets USP, 400 mg and 800
mg.
075132........................... Ranitidine Tablets USP, EQ 75 mg
base.
075439........................... Ranitidine Tablets USP, EQ 150 mg
base and EQ 300 mg base.
076041........................... Sotret (isotretinoin) Capsules USP,
10 mg, 20 mg, and 40 mg.
076285........................... Simvastatin Tablets USP, 5 mg, 10 mg,
20 mg, 40 mg, and 80 mg.
076332........................... Fluconazole for Oral Suspension, 10
mg/mL and 40 mg/mL.
076409........................... Nefazodone Hydrochloride Tablets USP,
50 mg, 100 mg, 150 mg, 200 mg, and
250 mg.
076503........................... Sotret (isotretinoin) Capsules USP,
30 mg.
076606........................... Gabapentin Capsules USP, 100 mg, 300
mg, and 400 mg.
076739........................... Fosinopril Sodium and
Hydrochlorothiazide Tablets USP, 10
mg/12.5 mg and 20 mg/12.5 mg.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner,
approval of the applications listed in the table, and all amendments
and supplements thereto, is hereby withdrawn, effective January 19,
2017.
Dated: December 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30623 Filed 12-19-16; 8:45 am]
BILLING CODE 4164-01-P
