Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications, 26058-26059 [2021-09980]
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Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
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Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09964 Filed 5–11–21; 8:45 am]
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
June 11, 2021.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0390]
Lederle Laboratories et al.; Withdrawal
of Approval of 12 Abbreviated New
Drug Applications
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
ANDA 060164 .............
Nystatin Ointment ................................................................
ANDA 060521 .............
ANDA 061034 .............
Humatin (paromomycin sulfate) Capsules, Equivalent to
(EQ) 250 milligrams (mg)/base.
Lincomycin Hydrochloride (HCl) ..........................................
Lederle Laboratories, Division of American Cyanamid Co.,
P.O. Box 8299, Pearl River, NY 10965.
King Pharmaceuticals, 501 5th St., Bristol, TN 37620.
ANDA 061652 .............
ANDA 061701 .............
Oxytetracycline ....................................................................
Tetracycline ..........................................................................
ANDA 062032 .............
ANDA 076490 .............
Erypar (erythromycin stearate) Tablets, EQ 250 mg/base
and EQ 500 mg/base.
Lithium Carbonate Extended-Release Tablets, 450 mg .....
ANDA
ANDA
ANDA
ANDA
.............
.............
.............
.............
Triamcinolone Acetonide Foam ...........................................
Chlorpromazine HCl Tablets, 10 mg ...................................
Butalbital; Aspirin; Phenacetin; Caffeine, Tablets ...............
Ranitidine HCl Syrup, EQ 15 mg base/milliliters .................
ANDA 206736 .............
Rifampin for Injection, 600 mg/vial ......................................
083001
084803
087635
090102
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 11, 2021.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
VerDate Sep<11>2014
17:58 May 11, 2021
Jkt 253001
The Upjohn Co. (formerly Pharmacia and Upjohn Co.),
7000 Portage Rd., Kalamazoo, MI 49001.
Parke Davis, 201 Tabor Rd., Morris Plains, NJ 07950.
Wyeth Pharmaceuticals, 1211 Sherwood Ave., Richmond,
VA 23220.
Parke Davis.
Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
Lederle Laboratories.
Do.
Do.
Torrent Pharma Inc., 150 Allen Rd., Suite 102, Basking
Ridge, NJ 07920.
Watson Pharmaceuticals, Inc. (an indirect, wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc.), 400
Interpace Pkwy., Building A, Parsippany, NJ 07054.
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
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products that are listed in the table that
are in inventory on June 11, 2021 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
E:\FR\FM\12MYN1.SGM
12MYN1
Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices
Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09980 Filed 5–11–21; 8:45 am]
Department of Health and Human
Services, Room L616, Switzer Building,
330 C. St. SW, Washington, DC 20024.
Phone: 202–746–1512; Email: CARB@
hhs.gov.
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB). The meeting will be open
to the public via WebEx and
teleconference; a pre-registered public
comment session will be held during
the meeting. Pre-registration is required
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teleconference. Individuals who wish to
send in their written public comment
should send an email to CARB@hhs.gov.
Registration information is available on
the website https://www.hhs.gov/paccarb
and must be completed by June 25,
2021. Additional information about
registering for the meeting and
providing public comment can be
obtained at https://www.hhs.gov/paccarb
on the Meetings page.
DATES: The meeting is scheduled to be
held on June 29, 2021, from 10:00 a.m.
to 3:00 p.m. and June 30, 2021, from
10:00 a.m. to 3:00 p.m. ET (times are
tentative and subject to change). The
confirmed times and agenda items for
the meeting will be posted on the
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www.hhs.gov/paccarb when this
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ADDRESSES: Instructions regarding
attending this meeting virtually will be
posted one week prior to the meeting at:
https://www.hhs.gov/paccarb.
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, M.S., Ph.D.,
Designated Federal Officer, Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria, Office of
the Assistant Secretary for Health, U.S.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:58 May 11, 2021
Jkt 253001
The
Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB), established by Executive
Order 13676, is continued by Section
505 of Public Law 116–22, the
Pandemic and All-Hazards
Preparedness and Advancing Innovation
Act of 2019 (PAHPAIA). Activities and
duties of the Advisory Council are
governed by the provisions of the
Federal Advisory Committee Act
(FACA), Public Law 92–463, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of federal advisory committees.
The PACCARB shall advise and
provide information and
recommendations to the Secretary
regarding programs and policies
intended to reduce or combat antibioticresistant bacteria that may present a
public health threat and improve
capabilities to prevent, diagnose,
mitigate, or treat such resistance. The
PACCARB shall function solely for
advisory purposes.
Such advice, information, and
recommendations may be related to
improving: The effectiveness of
antibiotics; research and advanced
research on, and the development of,
improved and innovative methods for
combating or reducing antibiotic
resistance, including new treatments,
rapid point-of-care diagnostics,
alternatives to antibiotics, including
alternatives to animal antibiotics, and
antimicrobial stewardship activities;
surveillance of antibiotic-resistant
bacterial infections, including publicly
available and up-to-date information on
resistance to antibiotics; education for
health care providers and the public
with respect to up-to-date information
on antibiotic resistance and ways to
reduce or combat such resistance to
antibiotics related to humans and
animals; methods to prevent or reduce
the transmission of antibiotic-resistant
bacterial infections; including
stewardship programs; and coordination
with respect to international efforts in
order to inform and advance the United
States capabilities to combat antibiotic
resistance.
The June 29–30, 2021, public meeting
will be dedicated to the council’s
deliberation and vote on two reports to
transmit to the Secretary of Health and
Human Services, the first from the
Disparities in Antibiotics Access and
Use Working Group, and the second
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26059
from the Working Group on
Antimicrobial Resistance (AMR) in
Inter-Professional Education. The
remainder of the two-day public
meeting will include an update on the
status of the antibiotic development
pipeline and an open council discussion
on provocative questions in AMR (no
recommendations will be made), in
addition to presentations from subject
matter experts on Operationalizing One
Health and the Environmental
Dimensions of AMR. The meeting
agenda will be posted on the PACCARB
website at https://www.hhs.gov/paccarb
when it has been finalized. All agenda
items are tentative and subject to
change.
Instructions regarding attending this
meeting virtually will be posted one
week prior to the meeting at: https://
www.hhs.gov/paccarb.
Members of the public will have the
opportunity to provide comments live
during the meeting via conference line
by pre-registering online at https://
www.hhs.gov/paccarb. There will be
two separate sessions available for
public comment: An Innovation
Spotlight will be held on June 29th
where companies and/or organizations
involved in combating antibiotic
resistance have an opportunity to
present their work to members of the
Advisory Council; and on June 30th,
where all members of the general public
are welcome to provide oral comment
during this separate session. Preregistration is required for participation
in these sessions with limited spots
available. Further information about
these two sessions can be found online
at https://www.hhs.gov/paccarb. Written
public comments can also be emailed to
CARB@hhs.gov by midnight June 25,
2021 and should be limited to no more
than one page. All public comments
received prior to June 25, 2021, will be
provided to Advisory Council members.
Dated: April 30, 2021.
Jomana F. Musmar,
Designated Federal Officer, Presidential
Advisory Council on Combating AntibioticResistant Bacteria, Office of the Assistant
Secretary for Health.
[FR Doc. 2021–10014 Filed 5–11–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26058-26059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0390]
Lederle Laboratories et al.; Withdrawal of Approval of 12
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 12 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of June 11, 2021.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 060164................ Nystatin Ointment.... Lederle
Laboratories,
Division of
American Cyanamid
Co., P.O. Box 8299,
Pearl River, NY
10965.
ANDA 060521................ Humatin (paromomycin King
sulfate) Capsules, Pharmaceuticals,
Equivalent to (EQ) 501 5th St.,
250 milligrams (mg)/ Bristol, TN 37620.
base.
ANDA 061034................ Lincomycin The Upjohn Co.
Hydrochloride (HCl). (formerly Pharmacia
and Upjohn Co.),
7000 Portage Rd.,
Kalamazoo, MI
49001.
ANDA 061652................ Oxytetracycline...... Parke Davis, 201
Tabor Rd., Morris
Plains, NJ 07950.
ANDA 061701................ Tetracycline......... Wyeth
Pharmaceuticals,
1211 Sherwood Ave.,
Richmond, VA 23220.
ANDA 062032................ Erypar (erythromycin Parke Davis.
stearate) Tablets,
EQ 250 mg/base and
EQ 500 mg/base.
ANDA 076490................ Lithium Carbonate Hikma
Extended-Release Pharmaceuticals USA
Tablets, 450 mg. Inc., 1809 Wilson
Rd., Columbus, OH
43228.
ANDA 083001................ Triamcinolone Lederle
Acetonide Foam. Laboratories.
ANDA 084803................ Chlorpromazine HCl Do.
Tablets, 10 mg.
ANDA 087635................ Butalbital; Aspirin; Do.
Phenacetin;
Caffeine, Tablets.
ANDA 090102................ Ranitidine HCl Syrup, Torrent Pharma Inc.,
EQ 15 mg base/ 150 Allen Rd.,
milliliters. Suite 102, Basking
Ridge, NJ 07920.
ANDA 206736................ Rifampin for Watson
Injection, 600 mg/ Pharmaceuticals,
vial. Inc. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ
07054.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
11, 2021. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on June 11, 2021 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
[[Page 26059]]
Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09980 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P
