Sanofi-Aventis U.S. LLC, et.al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications, 68888-68889 [2020-24012]
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
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Dated: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24028 Filed 10–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2088]
Sanofi-Aventis U.S. LLC, et.al.;
Withdrawal of Approval of 11
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 11 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applications be withdrawn.
DATES: Approval is withdrawn as of
November 30, 2020.
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.
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 § 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.
SUMMARY:
Application No.
Drug
Applicant
ANDA 061884 ......................
Rifamate (isoniazid and rifampin) Capsules, 150 milligrams (mg); 300 mg.
Ceftazidime for Injection, 1 gram(g)/vial .........................
Sanofi-Aventis U.S. LLC 55 Corporate Dr., Bridgewater,
NJ 08807.
Morton Grove Pharmaceuticals Inc./Wockhardt USA
LLC., 6451 Main St., Morton Grove, IL 60053.
Do.
ANDA 065196 ......................
ANDA 065197 ......................
ANDA 078229 ......................
ANDA 081134 ......................
ANDA 091659 ......................
jbell on DSKJLSW7X2PROD with NOTICES
approximate time each comment is to
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websites are subject to change over time.
Transcripts: Please be advised that as
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Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
industry/biosimilar-user-feeamendments/public-meetingreauthorization-biosimilar-user-fee-actbsufa-11192020-11192020.
Cefotaxime for Injection, Equivalent to (EQ) 1 g base/
vial; EQ 2 g base/vial; EQ 500 mg base/vial.
Terbinafine Hydrochloride (HCl) Tablets, EQ 250 mg
base.
Niacin Tablets, 500 mg ...................................................
Heparin Sodium Injection, 5,000 units/milliliter (mL) ......
ANDA 202647 ......................
Granisetron HCl Injection, EQ 0.1 mg base/mL (EQ 0.1
mg base/mL).
ANDA 202648 ......................
ANDA 205173 ......................
Granisetron HCl Injection, EQ 1 mg base/mL (EQ 1 mg
base/mL); EQ 4 mg base/4 mL (EQ 1 mg base/mL).
Bosentan Tablets, 62.5 mg and 125 mg ........................
ANDA 207843 ......................
Telmisartan Tablets, 20 mg, 40 mg, and 80 mg ............
VerDate Sep<11>2014
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Do.
Do.
CASI Pharmaceuticals, Inc., 9620 Medical Center Dr.,
Suite 300, Rockville, MD 20850.
Yung Shin Pharmaceutical Industrial Co., Ltd./Carlsbad
Technology, Inc., 5922 Farnsworth Ct., Carlsbad, CA
92008.
Do.
Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd.,
P.O. Box 4310, Morgantown, WV 26504.
Hisun Pharmaceutical (Hangzhou) Co., Ltd./Hisun
Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd
Floor, Bridgewater, NJ 08807.
E:\FR\FM\30OCN1.SGM
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
68889
Application No.
Drug
Applicant
ANDA 210681 ......................
Ranitidine HCl Capsules, EQ 150 mg base and EQ 300
mg base.
Novitium Pharma LLC, 70 Lake Dr., East Windsor, NJ
08520.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 30,
2020. 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 November 30,
2020 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: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24012 Filed 10–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Radiation
Exposure Screening and Education
Program, OMB No. 0906–0012—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
SUMMARY:
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than December 29,
2020.
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Radiation Exposure Screening and
Education Program, OMB No. 0906–
0012—Extension.
Abstract: The Radiation Exposure
Screening and Education Program
(RESEP) is authorized by section 417C
of the Public Health Service Act (42
U.S.C. 285a–9). The purpose of RESEP
is to assist individuals who live (or
lived) in areas where U.S. nuclear
weapons testing occurred and who are
diagnosed with cancer and other
radiogenic diseases caused by exposure
to nuclear fallout or nuclear materials
such as uranium. RESEP funds support
eligible health care organizations in:
Implementing cancer screening
programs; developing education
programs; disseminating information on
radiogenic diseases and the importance
of early detection; screening eligible
individuals for cancer and other
ADDRESSES:
radiogenic diseases; providing
appropriate referrals for medical
treatment; and facilitating
documentation of Radiation Exposure.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993 (Pub. L. 103–62).
These measures cover the principal
topic areas of interest to the Federal
Office of Rural Health Policy, including:
(a) Demographics for the RESEP
program user population; (b) medical
screening activities for cancers and
other radiogenic diseases; (c) exposure
and presentation types for eligible
radiogenic malignant and nonmalignant
diseases; (d) referrals for appropriate
medical treatment; (e) eligibility
counseling and referral assistance for
the RECA; and (f) program outreach and
education activities. These measures
will speak to the Office’s progress
toward meeting the goals set.
Likely Respondents: Radiation
Exposure Screening and Education
Program award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to: Review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Radiation Expose Screening and Education Program ........
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responses per
respondent
Number of
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burden per
response
(in hours)
Total
responses
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8
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Total burden
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96
96
]]>Agencies
[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Pages 68888-68889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24012]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2088]
Sanofi-Aventis U.S. LLC, et.al.; Withdrawal of Approval of 11
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 11 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 November 30, 2020.
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 061884................. Rifamate (isoniazid Sanofi-Aventis U.S.
and rifampin) LLC 55 Corporate
Capsules, 150 Dr., Bridgewater,
milligrams (mg); NJ 08807.
300 mg.
ANDA 065196................. Ceftazidime for Morton Grove
Injection, 1 Pharmaceuticals
gram(g)/vial. Inc./Wockhardt USA
LLC., 6451 Main
St., Morton Grove,
IL 60053.
ANDA 065197................. Cefotaxime for Do.
Injection,
Equivalent to (EQ)
1 g base/vial; EQ 2
g base/vial; EQ 500
mg base/vial.
ANDA 078229................. Terbinafine Do.
Hydrochloride (HCl)
Tablets, EQ 250 mg
base.
ANDA 081134................. Niacin Tablets, 500 Do.
mg.
ANDA 091659................. Heparin Sodium CASI
Injection, 5,000 Pharmaceuticals,
units/milliliter Inc., 9620 Medical
(mL). Center Dr., Suite
300, Rockville, MD
20850.
ANDA 202647................. Granisetron HCl Yung Shin
Injection, EQ 0.1 Pharmaceutical
mg base/mL (EQ 0.1 Industrial Co.,
mg base/mL). Ltd./Carlsbad
Technology, Inc.,
5922 Farnsworth
Ct., Carlsbad, CA
92008.
ANDA 202648................. Granisetron HCl Do.
Injection, EQ 1 mg
base/mL (EQ 1 mg
base/mL); EQ 4 mg
base/4 mL (EQ 1 mg
base/mL).
ANDA 205173................. Bosentan Tablets, Mylan
62.5 mg and 125 mg. Pharmaceuticals
Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown,
WV 26504.
ANDA 207843................. Telmisartan Tablets, Hisun Pharmaceutical
20 mg, 40 mg, and (Hangzhou) Co.,
80 mg. Ltd./Hisun
Pharmaceuticals
USA, Inc., 200
Crossing Blvd., 2nd
Floor, Bridgewater,
NJ 08807.
[[Page 68889]]
ANDA 210681................. Ranitidine HCl Novitium Pharma LLC,
Capsules, EQ 150 mg 70 Lake Dr., East
base and EQ 300 mg Windsor, NJ 08520.
base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 30, 2020. 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 November 30, 2020 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: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24012 Filed 10-29-20; 8:45 am]
BILLING CODE 4164-01-P
