Bristol-Meyers Squibb Company, et al.; Withdrawal of Approval of 19 New Drug Applications, 14447-14448 [2021-05368]
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05371 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0212]
Bristol-Meyers Squibb Company, et al.;
Withdrawal of Approval of 19 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 19 new drug
applications (NDAs) 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applications be withdrawn.
DATES: Approval is withdrawn as of
April 15, 2021.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
SUMMARY:
Application No.
Drug
NDA 009218 ......
NDA 017481 ......
Coumadin (warfarin sodium) Tablets, 1 milligram (mg), 2 mg,
2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg.
Coumadin (warfarin sodium) Injection, 5 mg/vial, 50 mg/vial,
and 75 mg/vial.
Decadron (dexamethasone) Tablets, 0.25 mg, 0.5 mg, 0.75
mg, 1.5 mg, 4 mg, and 6 mg.
Vermox (mebendazole) Chewable Tablets, 100 mg ...............
NDA 018538 ......
Lozol (indapamide) Tablets, 1.25 mg, and 2.5 mg ..................
NDA 018986 ......
Pralidoxime Chloride Injection (auto-injector), 600 mg/2 milliliters (mL) (300 mg/mL).
Morphine Sulfate Injection (auto-injector), 10 mg/0.7 mL .......
Famvir (famciclovir) Tablets, 125 mg, 250 mg, and 500 mg ...
NDA 011664 ......
NDA 019999 ......
NDA 020363 ......
NDA 020711 ......
NDA 020809 ......
NDA 021713 ......
Abilify (aripiprazole) Oral Solution, 1 mg/mL ...........................
NDA 021729 ......
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets,
10 mg, 15 mg, 20 mg, and 30 mg.
Abilify (aripiprazole) Injection, 9.75 mg/1.3 mL (7.5 mg/mL) ...
Actoplus Met XR (metformin HCl and pioglitazone) ExtendedRelease Tablets, 1gram (g)/Equivalent to (EQ) 15 mg base
and 1 g/EQ 30 mg base.
Ceftin (cefuroxime axetil) Tablets, EQ 125 mg base, EQ 250
mg base, and EQ 500 mg base.
NDA 050605 ......
NDA 050672 ......
NDA 207988 ......
Ceftin (cefuroxime axetil) Oral Suspension, EQ 125 mg base/
5 mL and EQ 250 mg base/5 mL.
Zurampic (lesinurad) Tablets, 200mg ......................................
NDA 208383 ......
Bevyxxa (betrixaban) Capsules, 40 mg and 80 mg ................
NDA 210709 ......
Tekturna (aliskiren hemifumarate) Capsules (Pellets), EQ
37.5 mg base.
Qternmet XR (dapagliflozin, metformin HCl and saxagliptin)
Extended-Release Tablets, 2.5 mg/1 g/EQ 2.5 mg base, 5
mg/1 g/EQ 2.5 mg base, 5 mg/1 g/EQ 5 mg base, and 10
mg/1 g/EQ 5 mg base.
NDA 210874 ......
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 15,
2021. Approval of each entire
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
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 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:
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc., 1 Merck Dr., Whitehouse Station, NJ 08889.
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton
Rd., Titusville, NJ 08560.
Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ
08807.
Meridian Medical Technologies, Inc., 1945 Craig Rd., St.
Louis, MO 63146.
Do.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936–1080.
GlaxoSmithKline LLC, 5 Crescent Dr., Philadelphia, PA
19112.
Alcon Research, LLC, 6201 South Freeway, Fort Worth, TX
76134.
Otsuka Pharmaceutical Co., Ltd. c/o Otsuka Pharmaceutical
Development & Commercialization, Inc., 2440 Research
Blvd., Rockville, MD 20850.
Do.
Do.
Takeda Pharmaceutical U.S.A. Inc., 95 Hayden Ave., Lexington, MA 02421.
GlaxoSmithKline Intellectual Property (no. 2) Ltd. England, c/
o GlaxoSmithKline, 1250 South Collegeville Rd.,
Collegeville, PA 19426.
Do.
Ironwood Pharmaceuticals, Inc., 100 Summer St., Suite
2300, Boston MA 02110.
Portola Pharmaceuticals, Inc., 270 East Grand Ave., South
San Francisco, CA 94080.
Nodem Pharma DAC, 4820 Emperor Blvd., Durham, NC
27703.
AstraZeneca AB, c/o AstraZeneca Pharmaceuticals LP, 1800
Concord Pike, Wilmington, DE 19803.
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
PO 00000
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
Applicant
Zyban (bupropion hydrochloride (HCl)) Extended-Release
Tablets, 100 mg, and 150 mg.
Diclofenac Sodium Ophthalmic Solution, 0.1% .......................
NDA 021866 ......
NDA 022024 ......
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
14447
Frm 00045
Fmt 4703
Sfmt 4703
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
E:\FR\FM\16MRN1.SGM
16MRN1
14448
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
that are in inventory on April 15, 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.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05368 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2002–N–0314]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Request for
Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements relating to the
regulations that state that protocols for
samples of biological products must be
submitted to the Agency.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 17, 2021.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 17, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 17, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
jbell on DSKJLSW7X2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2002–N–0314 for ‘‘Request for Samples
and Protocols.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
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made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
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as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16MRN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14447-14448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05368]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0212]
Bristol-Meyers Squibb Company, et al.; Withdrawal of Approval of
19 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 19 new drug applications (NDAs) 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 April 15, 2021.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [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 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
------------------------------------------------------------------------
NDA 009218............. Coumadin (warfarin Bristol-Myers Squibb
sodium) Tablets, 1 Co., P.O. Box 4000,
milligram (mg), 2 mg, Princeton, NJ 08543.
2.5 mg, 3 mg, 4 mg, 5
mg, 6 mg, 7.5 mg, and
10 mg.
Coumadin (warfarin
sodium) Injection, 5
mg/vial, 50 mg/vial,
and 75 mg/vial.
NDA 011664............. Decadron Merck Sharp & Dohme
(dexamethasone) Corp., a subsidiary
Tablets, 0.25 mg, 0.5 of Merck & Co., Inc.,
mg, 0.75 mg, 1.5 mg, 4 1 Merck Dr.,
mg, and 6 mg. Whitehouse Station,
NJ 08889.
NDA 017481............. Vermox (mebendazole) Janssen
Chewable Tablets, 100 Pharmaceuticals,
mg. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ 08560.
NDA 018538............. Lozol (indapamide) Sanofi-aventis U.S.
Tablets, 1.25 mg, and LLC, 55 Corporate
2.5 mg. Dr., Bridgewater, NJ
08807.
NDA 018986............. Pralidoxime Chloride Meridian Medical
Injection (auto- Technologies, Inc.,
injector), 600 mg/2 1945 Craig Rd., St.
milliliters (mL) (300 Louis, MO 63146.
mg/mL).
NDA 019999............. Morphine Sulfate Do.
Injection (auto-
injector), 10 mg/0.7
mL.
NDA 020363............. Famvir (famciclovir) Novartis
Tablets, 125 mg, 250 Pharmaceuticals
mg, and 500 mg. Corp., 1 Health
Plaza, East Hanover,
NJ 07936-1080.
NDA 020711............. Zyban (bupropion GlaxoSmithKline LLC, 5
hydrochloride (HCl)) Crescent Dr.,
Extended-Release Philadelphia, PA
Tablets, 100 mg, and 19112.
150 mg.
NDA 020809............. Diclofenac Sodium Alcon Research, LLC,
Ophthalmic Solution, 6201 South Freeway,
0.1%. Fort Worth, TX 76134.
NDA 021713............. Abilify (aripiprazole) Otsuka Pharmaceutical
Oral Solution, 1 mg/mL. Co., Ltd. c/o Otsuka
Pharmaceutical
Development &
Commercialization,
Inc., 2440 Research
Blvd., Rockville, MD
20850.
NDA 021729............. Abilify (aripiprazole) Do.
Discmelt Orally
Disintegrating
Tablets, 10 mg, 15 mg,
20 mg, and 30 mg.
NDA 021866............. Abilify (aripiprazole) Do.
Injection, 9.75 mg/1.3
mL (7.5 mg/mL).
NDA 022024............. Actoplus Met XR Takeda Pharmaceutical
(metformin HCl and U.S.A. Inc., 95
pioglitazone) Extended- Hayden Ave.,
Release Tablets, 1gram Lexington, MA 02421.
(g)/Equivalent to (EQ)
15 mg base and 1 g/EQ
30 mg base.
NDA 050605............. Ceftin (cefuroxime GlaxoSmithKline
axetil) Tablets, EQ Intellectual Property
125 mg base, EQ 250 mg (no. 2) Ltd. England,
base, and EQ 500 mg c/o GlaxoSmithKline,
base. 1250 South
Collegeville Rd.,
Collegeville, PA
19426.
NDA 050672............. Ceftin (cefuroxime Do.
axetil) Oral
Suspension, EQ 125 mg
base/5 mL and EQ 250
mg base/5 mL.
NDA 207988............. Zurampic (lesinurad) Ironwood
Tablets, 200mg. Pharmaceuticals,
Inc., 100 Summer St.,
Suite 2300, Boston MA
02110.
NDA 208383............. Bevyxxa (betrixaban) Portola
Capsules, 40 mg and 80 Pharmaceuticals,
mg. Inc., 270 East Grand
Ave., South San
Francisco, CA 94080.
NDA 210709............. Tekturna (aliskiren Nodem Pharma DAC, 4820
hemifumarate) Capsules Emperor Blvd.,
(Pellets), EQ 37.5 mg Durham, NC 27703.
base.
NDA 210874............. Qternmet XR AstraZeneca AB, c/o
(dapagliflozin, AstraZeneca
metformin HCl and Pharmaceuticals LP,
saxagliptin) Extended- 1800 Concord Pike,
Release Tablets, 2.5 Wilmington, DE 19803.
mg/1 g/EQ 2.5 mg base,
5 mg/1 g/EQ 2.5 mg
base, 5 mg/1 g/EQ 5 mg
base, and 10 mg/1 g/EQ
5 mg base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
15, 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
[[Page 14448]]
that are in inventory on April 15, 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.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05368 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P
