Allergan Sales, LLC, et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications, 70835-70836 [2022-25315]
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Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / Notices
III. Participating in the Public Meeting
Registration: Persons interested in
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WN_DBPaDGi5QXaaCoxkJkx7g no later
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CONTACT) no later than December 1,
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Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25274 Filed 11–18–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2826]
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 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applications be withdrawn.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Approval is withdrawn as of
December 21, 2022.
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:
Allergan Sales, LLC, et al.; Withdrawal
of Approval of 10 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
ANDA 040099 ....
Norco (hydrocodone bitartrate and acetaminophen) Tablets,
5 milligrams (mg)/325 mg.
ANDA 040148 ....
Norco (hydrocodone bitartrate and acetaminophen) Tablets,
2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325
mg, and 10 mg/500 mg.
Chlorhexidine Gluconate Solution, 0.12% ...............................
Allergan Sales, LLC, U.S. Agent for Allergan Pharmaceuticals International Limited, 5 Giralda Farms, Madison,
NJ 07940.
Do.
ANDA 076434 ....
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approximate time each oral presentation
is to begin, and we will notify
participants by December 5, 2022. All
requests to make oral presentations
must be received by December 1, 2022,
11:59 p.m. Eastern Time. If selected for
presentation, any presentation materials
must be emailed to Lisa Kable (see FOR
FURTHER INFORMATION CONTACT) no later
than December 5, 2022. No commercial
or promotional material will be
permitted to be presented at the public
meeting.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
industry/animal-drug-user-fee-actadufa/adufa-meetings.
70835
ANDA 079076 ....
Ranitidine Hydrochloride (HCl) Injection, Equivalent to (EQ)
25 mg base/milliliters (mL).
ANDA 090054 ....
ANDA 201804 ....
Ranitidine HCl Syrup, EQ 15 mg base/mL ..............................
Letrozole Tablets, 2.5 mg ........................................................
ANDA 201832 ....
Nimodipine Capsules, 30 mg ...................................................
ANDA 203419 ....
ANDA 203519 ....
Donepezil HCl Tablets, 23 mg .................................................
Morphine Sulfate Solution, 20 mg/5 mL ..................................
ANDA 206151 ....
Abacavir Sulfate and Lamivudine Tablets, EQ 600 mg base;
300 mg.
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21:25 Nov 18, 2022
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Sunstar Americas, Inc., 301 East Central Rd., Schaumburg,
IL 60195.
Mylan Pharmaceuticals Inc., a Viatris Company, U.S. Agent
for Mylan Laboratories Limited, 3711 Collins Ferry Rd.,
Morgantown, WV 26505.
Tolmar Inc., 701 Centre Ave., Fort Collins, CO 80526.
Indicus Pharma, LLC, 2530 Meridian Parkway, Durham, NC
27713.
Sofgen Pharmaceuticals, LLC, 21500 Biscayne Blvd., Suite
600, Aventura, FL 33180.
Indicus Pharma, LLC.
Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth
Junction, NJ 08852.
Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo
Pharma Limited, 279 Princeton-Hightstown Rd., East
Windsor, NJ 08520.
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70836
Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of December 21,
2022. 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 December 21,
2022 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.
Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25315 Filed 11–18–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Input on the National Public Health
Strategy for the Prevention and
Control of Vector-Borne Diseases in
Humans: Request for Information
Office of the Assistant
Secretary for Health (OASH), Office of
the Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Request for information.
This Request for information
(RFI) invites comments and suggestions
on the National Strategy for the
Prevention and Control of Vector-Borne
Diseases. The Strategy represents the
Federal Government’s priorities for
addressing vector-borne disease (VBD)
threats.
SUMMARY:
To be assured consideration,
comments must be received via the
method provided below, no later than
midnight Eastern Time (ET) on
December 21, 2022. Submissions
received after the deadline will not be
reviewed.
ADDRESSES: Comments, including mass
comment submissions, must be
submitted electronically at https://
www.regulations.gov. Search for this RFI
by typing a keyword in the search field
on the homepage. Click on the
‘‘Comment Now’’ button on RFI and you
can submit your comments including
attachments in a window titled, ‘‘Your
Information.’’ For help finding this RFI
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DATES:
VerDate Sep<11>2014
21:25 Nov 18, 2022
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and/or submitting comments, please
visit https://www.regulations.gov/help.
FOR FURTHER INFORMATION CONTACT: Dr.
Kristen Honey, Chief Data Scientist and
Executive Director of InnovationX,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services, 200 Independence
Avenue SW, Washington, DC 20201,
vectorbornedisease@hhs.gov, (202) 853–
7680.
SUPPLEMENTARY INFORMATION: It is
important to read this entire RFI notice
to ensure an adequate response is
prepared and to have a full
understanding of how your response
will be acknowledged and used.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: https://
www.regulations.gov. Follow the search
instructions on that website to view
public comments.
I. Background
The Federal Government is
developing a national strategy for the
prevention and control of vector-borne
diseases (VBD) in humans.
The Federal Government has
identified 5 goals and 19 strategic
priorities which were developed using
the framework of the previously
released National Public Health
Framework for the Prevention and
Control of Vector-Borne Diseases in
Humans:
• Goal 1: Better understand when,
where, and how people are exposed to
and become sick or die from vectorborne diseases (VBDs).
Æ Strategic Priority 1: Better
understand vectors, the pathogens they
transmit, and the potential effects of a
changing climate.
Æ Strategic Priority 2: Modernize and
maintain surveillance systems for
vectors, reservoirs, and VBDs.
Æ Strategic Priority 3: Better
understand the risk factors for and
effects of VBDs on humans.
• Goal 2: Develop, evaluate, and
improve tools and guidance for the
diagnosis and detection of vector-borne
diseases.
Æ Strategic Priority 1: Identify and
characterize novel VBD pathogens and
their clinical manifestations.
Æ Strategic Priority 2: Develop,
evaluate, and improve diagnostic tests
for VBDs.
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Æ Strategic Priority 3: Develop and
evaluate evidence-based
recommendations and guidelines on
VBD diagnosis in humans.
Æ Strategic Priority 4: Develop,
maintain, and distribute noncommercial diagnostic resources to
facilitate VBD testing.
• Goal 3: Develop, evaluate, and
improve tools and guidance for the
prevention and control of vector-borne
diseases.
Æ Strategic Priority 1: Develop,
evaluate, and improve safe and effective
VBD prevention tools such as vaccines,
vector control strategies, and health
communication tools and products that
are tailored for communities that are
disproportionately affected.
Æ Strategic Priority 2: Develop and
evaluate data-driven and adaptive
predictive models and decision support
tools for VBDs.
Æ Strategic Priority 3: Develop and
evaluate evidence-based
recommendations and guidelines on
VBD prevention.
Æ Strategic Priority 4: Develop and
evaluate tools and processes for
responding to public health
emergencies.
• Goal 4: Develop and assess drugs
and treatment strategies for VBDs.
Æ Strategic Priority 1: Identify,
develop, and evaluate safe and effective
drugs and treatment strategies
(regimens) for VBDs.
Æ Strategic Priority 2: Develop
evidence-based recommendations and
guidelines on the treatment and
management of VBDs.
Æ Strategic Priority 3: Evaluate drug
and treatment use patterns.
• Goal 5: Disseminate and support
the implementation of effective public
health products, tools, programs,
collaborations, and innovations to
prevent, detect, diagnose, and respond
to VBD threats.
Æ Strategic Priority 1: Disseminate
evidence-based information about VBD
prevention and control, guidelines, and
recommendations to partners and the
public.
Æ Strategic Priority 2: Ensure current
and future capacity to implement and
adequately and equitably scale safe,
effective, and publicly accepted VBD
prevention and control programs.
Æ Strategic Priority 3: Monitor and
evaluate evidence-based public health
programs and tools.
Æ Strategic Priority 4: Respond to
public health emergencies resulting
from VBD threats.
Æ Strategic Priority 5: Clarify,
facilitate, and improve processes to
bring regulated diagnostic tests,
treatment strategies, vaccines, and
vector control products to market.
E:\FR\FM\21NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70835-70836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25315]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2826]
Allergan Sales, LLC, et al.; Withdrawal of Approval of 10
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 10 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 December 21, 2022.
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 040099................. Norco (hydrocodone bitartrate and Allergan Sales, LLC, U.S. Agent for
acetaminophen) Tablets, 5 milligrams Allergan Pharmaceuticals International
(mg)/325 mg. Limited, 5 Giralda Farms, Madison, NJ
07940.
ANDA 040148................. Norco (hydrocodone bitartrate and Do.
acetaminophen) Tablets, 2.5 mg/325 mg,
5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325
mg, and 10 mg/500 mg.
ANDA 076434................. Chlorhexidine Gluconate Solution, 0.12%. Sunstar Americas, Inc., 301 East Central
Rd., Schaumburg, IL 60195.
ANDA 079076................. Ranitidine Hydrochloride (HCl) Mylan Pharmaceuticals Inc., a Viatris
Injection, Equivalent to (EQ) 25 mg Company, U.S. Agent for Mylan
base/milliliters (mL). Laboratories Limited, 3711 Collins
Ferry Rd., Morgantown, WV 26505.
ANDA 090054................. Ranitidine HCl Syrup, EQ 15 mg base/mL.. Tolmar Inc., 701 Centre Ave., Fort
Collins, CO 80526.
ANDA 201804................. Letrozole Tablets, 2.5 mg............... Indicus Pharma, LLC, 2530 Meridian
Parkway, Durham, NC 27713.
ANDA 201832................. Nimodipine Capsules, 30 mg.............. Sofgen Pharmaceuticals, LLC, 21500
Biscayne Blvd., Suite 600, Aventura, FL
33180.
ANDA 203419................. Donepezil HCl Tablets, 23 mg............ Indicus Pharma, LLC.
ANDA 203519................. Morphine Sulfate Solution, 20 mg/5 mL... Tris Pharma, Inc., 2033 Route 130, Suite
D, Monmouth Junction, NJ 08852.
ANDA 206151................. Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma USA, Inc., U.S. Agent
EQ 600 mg base; 300 mg. for Aurobindo Pharma Limited, 279
Princeton-Hightstown Rd., East Windsor,
NJ 08520.
----------------------------------------------------------------------------------------------------------------
[[Page 70836]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 21, 2022. 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 December 21, 2022 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.
Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25315 Filed 11-18-22; 8:45 am]
BILLING CODE 4164-01-P
