Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications, 91410-91412 [2024-26913]
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91410
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–3482]
Determination That JESDUVROQ
(daprodustat) Tablets, 1 Milligram, 2
Milligrams, 4 Milligrams, 6 Milligrams,
and 8 Milligrams, Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that JESDUVROQ
(daprodustat) tablets, 1 milligram (mg),
2 mg, 4 mg, 6 mg, and 8 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Awo
Archampong-Gray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243,
Silver Spring, MD 20993–0002, 301–
796–0110, Awo.Archampong-Gray@
fda.hhs.gov.
SUMMARY:
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
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SUPPLEMENTARY INFORMATION:
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ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, are the
subject of NDA 216951, held by
GlaxoSmithKline Intellectual Property
(No. 2) Limited England, and initially
approved on February 1, 2023.
JESDUVROQ is a hypoxia-inducible
factor prolyl hydroxylase (HIF PH)
inhibitor indicated for the treatment of
anemia due to chronic kidney disease in
adults who have been receiving dialysis
for at least 4 months. JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Qilu Pharmaceutical (Hainan) Co.,
Ltd., submitted a citizen petition dated
July 24, 2024 (Docket No. FDA–2024–P–
3482), under 21 CFR 10.30, requesting
that the Agency determine whether
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
JESDUVROQ (daprodustat) tablets, 1
mg, 2 mg, 4 mg, 6 mg, and 8 mg, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list JESDUVROQ
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(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, and 8 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg,
6 mg, or 8 mg, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26915 Filed 11–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4860]
Pfizer, Inc., et al.; Withdrawal of
Approval of 26 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 26 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
December 19, 2024.
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, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in table 1 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.
SUMMARY:
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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
Withdrawal of approval of an
application or abbreviated application
91411
under § 314.150(c) is without prejudice
to refiling.
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Drug
NDA 012541 ........
NDA 020001 ........
Depo-Provera (medroxyprogesterone acetate) Injectable,
100 milligrams (mg)/milliliter (mL) and 400 mg/mL.
Diamox (acetazolamide) Extended-Release Capsules, 500
mg.
Deca-Durabolin (nandrolone decanoate) Injectable, 50 mg/
mL,100 mg/mL, and 200 mg/mL.
Corgard (nadolol) Tablets, 20 mg, 40 mg, 80 mg, 120 mg,
and 160 mg.
Diflucan in Dextrose 5% in Plastic Container (fluconazole),
Injectable, 200 mg/100 mL and 400 mg/200 mL.
Diflucan in Sodium Chloride 0.9% (fluconazole), Injectable,
200 mg/100 mL and 400 mg/200 mL.
Diflucan in Sodium Chloride 0.9% in Plastic Container
(fluconazole), Injectable, 200 mg/100 mL and 400 mg/200
mL.
Capex (fluocinolone acetonide) Shampoo, 0.01% ..................
NDA 020938 ........
Mobic (meloxicam) Tablets, 7.5 mg and 15 mg .....................
NDA 021333 ........
Minirin (desmopressin acetate) Metered Nasal Spray, 0.01
mg/spray.
Aloxi (palonosetron hydrochloride (HCl)) Injectable, Equivalent to (EQ) 0.075 mg base/1.5 mL and EQ 0.25 mg base/
5 mL.
Nexium IV (esomeprazole sodium) Injectable, EQ 20 mg
base/vial and EQ 40mg base/vial.
Patanase (olopatadine HCl) Metered Nasal Spray, 0.665
mg/spray.
Totect (dexrazoxane HCl) Injectable, EQ 500 mg base/vial ..
Gelnique (oxybutynin chloride) Transdermal Gel, 10% (100
mg/packet).
Aloxi (palonosetron HCl) Capsules, EQ 0.5 mg base ............
Differin (adapalene) Lotion, 0.1% ...........................................
Zuplenz (ondansetron) Oral Film, 4 mg and 8 mg .................
NDA 012945 ........
NDA 013132 ........
NDA 018063 ........
NDA 019950 ........
NDA 021372 ........
NDA 021689 ........
NDA 021861 ........
NDA 022025 ........
NDA 022204 ........
NDA 022233 ........
NDA 022502 ........
NDA 022524 ........
NDA 050297 ........
NDA 050611 ........
NDA 050824 ........
NDA 203667 ........
NDA 204427 ........
NDA 205103 ........
NDA 205383 ........
NDA 207930 ........
NDA 207923 ........
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NDA 216951 ........
Ery-Ped (erythromycin ethylsuccinate) Chewable Tablets,
EQ 200 mg base.
E.E.S. (erythromycin ethylsuccinate) Chewable Tablets, EQ
200 mg base.
PCE (erythromycin) Coated Particles in Tablets, 333 mg and
500 mg.
Omeclamox-Pak (amoxicillin Capsules, 500 mg;
clarithromycin Tablets, 500 mg; and omeprazole DelayedRelease Capsules, 20 mg).
Minastrin 24 Fe (ethinyl estradiol/norethindrone acetate)
Tablets, 0.02 mg/1 mg.
Kerydin (tavabarole) Topical Solution, 5% ..............................
Yosprala (aspirin/omeprazole) Delayed-Release Tablets, 81
mg/40 mg and 325 mg/40 mg.
Oraltag (iohexol) for Oral Solution, 9.7 gram/bottle ................
Utibron (glycopyrrolate, indacaterol maleate) Inhalation Powder, 15.6 microgram/inhaler and 27.5 microgram/inhaler.
Seebri Neohaler (glycopyrrolate) Inhalation Powder, 15.6
microgram/inhaler.
Jesduvroq (daprodustat) Tablets, 1 mg, 2 mg, 4 mg, 6 mg,
and 8 mg.
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of December 19,
2024. Approval of each entire
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Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
Teva Branded Pharmaceutical Products R&D, Inc., 145
Brandywine Parkway, West Chester, PA 19380.
Woodward Specialty, LLC, 16825 West 116th St., Lenexa,
KS 66219.
USWM, LLC, 4441 Springdale Rd., Louisville, KY 40241.
Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
Galderma Laboratories, L.P., 2001 Ross Ave., Suite 1600,
Dallas, TX 75201.
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury
Rd., Ridgefield, CT 06877.
Ferring Pharmaceuticals Inc., 100 Interpace Parkway, Parsippany, NJ 07054.
Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc.,
200 Wood Ave. South, Suite 100, Iselin, New Jersey
08830.
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
Clinigen, Inc., 45 Great Valley Parkway, Malvern, PA 19355.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
Helsinn Healthcare SA c/o Helsinn Therapeutics (U.S.), Inc.
Galderma Laboratories.
Aquestive Therapeutics, 30 Technology Dr., Warren, NJ
07059.
Azurity Pharmaceuticals, Inc., 8 Cabot Rd., Woburn, MA
01801.
Do.
Cumberland Pharmaceuticals Inc., 1600 West End Ave.,
Suite 1300, Nashville, TN 37203.
Allergan Pharmaceuticals International Ltd. c/o AbbVie Inc.,
1 N Waukegan Rd., North Chicago, IL 60064.
Anacor Pharmaceuticals Inc., 445 Eastern Point Rd., Groton, CT 06340.
Genus Lifesciences Inc., 514 North 12th St., Allentown, PA
18102.
Interpharma Praha AS c/o Otsuka Pharmaceutical Development and Commercialization Inc., 508 Carnegie Center
Dr., Princeton, NJ 08540.
Novartis Pharmaceuticals Corp.
Do.
GlaxoSmithKline Intellectual Property (No. 2) Ltd. England
c/o GSK, 2929 Walnut St., Suite 1700, Philadelphia, PA
19104.
application is withdrawn, including any
strengths and dosage forms included in
the application but inadvertently
missing from table 1. Introduction or
delivery for introduction into interstate
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commerce of products listed in table 1
without an approved NDA violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
are listed in table 1 that are in inventory
on December 19, 2024 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 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26913 Filed 11–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Rural Health Care Services
Outreach Program Measures
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than December 19,
2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
SUMMARY:
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Care Services Outreach
Program Measures, OMB No. 0906–
0009—Revision.
Abstract: The Rural Health Care
Services Outreach Program is
authorized by section 330A(e) of the
Public Health Service Act (42 U.S.C.
254c(e)) to ‘‘promote rural health care
services outreach by improving and
expanding the delivery of health care
services to include new and enhanced
services in rural areas.’’ The goals for
the Rural Health Care Services Outreach
Program are as follows: (1) expand the
delivery of health care services in rural
communities; (2) deliver health care
services through a strong consortium, in
which every consortium member
organization is actively involved and
engaged in the planning and delivery of
services; (3) utilize and/or adapt an
evidence-based or innovative, evidenceinformed model(s) in the delivery of
health care services; and (4) improve
population health and demonstrate
health outcomes and sustainability.
HRSA collects information from grant
recipients that participate in this
program using an OMB-approved set of
performance measures and seeks to
extend its approved information
collection.
A 60-day notice was published in the
Federal Register on June 21, 2024, 89
FR 52069–70. There were no public
comments. However, following
publication of the 60-day notice, HRSA
increased the average burden per
response and total burden hours due to
personnel changes resulting in training
needs of new hires common among
rural healthcare workforce in the
Outreach Program.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to the Federal Office of Rural
Health Policy (FORHP), including: (1)
access to care, (2) population
demographics, (3) consortium/network,
(4) sustainability, (5) project specific
domains, and (6) clinical measures. All
measures will speak to FORHP’s
progress toward meeting the goals set.
FORHP collects this information to
quantify the impact of grant funding on
access to health care, quality of services,
and improvement of health outcomes.
FORHP uses the data for program
improvement and grantees use the data
for performance tracking. No
substantive changes are proposed from
the current data collection effort;
FORHP proposes updating hyperlinks
for the clinical measures and including
an option for text entry to capture
names of counties for the number of
counties served measure.
Likely Respondents: The respondents
would be recipients of the Rural Health
Care Services Outreach Program grants.
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
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Rural Health Care Services Outreach Performance Measures ...................................................................................
61
1
61
8
488
Total ..............................................................................
61
........................
61
........................
488
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]]>Agencies
[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Pages 91410-91412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26913]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4860]
Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 26 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 December 19, 2024.
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 table 1 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.
[[Page 91411]]
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
Table 1--NDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 012541.................. Depo-Provera Pfizer Inc., 66
(medroxyprogesteron Hudson Blvd. East,
e acetate) New York, NY 10001.
Injectable, 100
milligrams (mg)/
milliliter (mL) and
400 mg/mL.
NDA 012945.................. Diamox Teva Branded
(acetazolamide) Pharmaceutical
Extended-Release Products R&D, Inc.,
Capsules, 500 mg. 145 Brandywine
Parkway, West
Chester, PA 19380.
NDA 013132.................. Deca-Durabolin Woodward Specialty,
(nandrolone LLC, 16825 West
decanoate) 116th St., Lenexa,
Injectable, 50 mg/ KS 66219.
mL,100 mg/mL, and
200 mg/mL.
NDA 018063.................. Corgard (nadolol) USWM, LLC, 4441
Tablets, 20 mg, 40 Springdale Rd.,
mg, 80 mg, 120 mg, Louisville, KY
and 160 mg. 40241.
NDA 019950.................. Diflucan in Dextrose Pfizer Inc., 66
5% in Plastic Hudson Blvd. East,
Container New York, NY 10001.
(fluconazole),
Injectable, 200 mg/
100 mL and 400 mg/
200 mL.
Diflucan in Sodium
Chloride 0.9%
(fluconazole),
Injectable, 200 mg/
100 mL and 400 mg/
200 mL.
Diflucan in Sodium
Chloride 0.9% in
Plastic Container
(fluconazole),
Injectable, 200 mg/
100 mL and 400 mg/
200 mL.
NDA 020001.................. Capex (fluocinolone Galderma
acetonide) Shampoo, Laboratories, L.P.,
0.01%. 2001 Ross Ave.,
Suite 1600, Dallas,
TX 75201.
NDA 020938.................. Mobic (meloxicam) Boehringer Ingelheim
Tablets, 7.5 mg and Pharmaceuticals,
15 mg. Inc., 900 Ridgebury
Rd., Ridgefield, CT
06877.
NDA 021333.................. Minirin Ferring
(desmopressin Pharmaceuticals
acetate) Metered Inc., 100 Interpace
Nasal Spray, 0.01 Parkway,
mg/spray. Parsippany, NJ
07054.
NDA 021372.................. Aloxi (palonosetron Helsinn Healthcare
hydrochloride SA c/o Helsinn
(HCl)) Injectable, Therapeutics
Equivalent to (EQ) (U.S.), Inc., 200
0.075 mg base/1.5 Wood Ave. South,
mL and EQ 0.25 mg Suite 100, Iselin,
base/5 mL. New Jersey 08830.
NDA 021689.................. Nexium IV AstraZeneca
(esomeprazole Pharmaceuticals LP,
sodium) Injectable, 1800 Concord Pike,
EQ 20 mg base/vial Wilmington, DE
and EQ 40mg base/ 19803.
vial.
NDA 021861.................. Patanase Novartis
(olopatadine HCl) Pharmaceuticals
Metered Nasal Corp., 1 Health
Spray, 0.665 mg/ Plaza, East
spray. Hanover, NJ 07936.
NDA 022025.................. Totect (dexrazoxane Clinigen, Inc., 45
HCl) Injectable, EQ Great Valley
500 mg base/vial. Parkway, Malvern,
PA 19355.
NDA 022204.................. Gelnique (oxybutynin AbbVie Inc., 1 North
chloride) Waukegan Rd., North
Transdermal Gel, Chicago, IL 60064.
10% (100 mg/packet).
NDA 022233.................. Aloxi (palonosetron Helsinn Healthcare
HCl) Capsules, EQ SA c/o Helsinn
0.5 mg base. Therapeutics
(U.S.), Inc.
NDA 022502.................. Differin (adapalene) Galderma
Lotion, 0.1%. Laboratories.
NDA 022524.................. Zuplenz Aquestive
(ondansetron) Oral Therapeutics, 30
Film, 4 mg and 8 mg. Technology Dr.,
Warren, NJ 07059.
NDA 050297.................. Ery-Ped Azurity
(erythromycin Pharmaceuticals,
ethylsuccinate) Inc., 8 Cabot Rd.,
Chewable Tablets, Woburn, MA 01801.
EQ 200 mg base.
E.E.S. (erythromycin
ethylsuccinate)
Chewable Tablets,
EQ 200 mg base.
NDA 050611.................. PCE (erythromycin) Do.
Coated Particles in
Tablets, 333 mg and
500 mg.
NDA 050824.................. Omeclamox-Pak Cumberland
(amoxicillin Pharmaceuticals
Capsules, 500 mg; Inc., 1600 West End
clarithromycin Ave., Suite 1300,
Tablets, 500 mg; Nashville, TN
and omeprazole 37203.
Delayed-Release
Capsules, 20 mg).
NDA 203667.................. Minastrin 24 Fe Allergan
(ethinyl estradiol/ Pharmaceuticals
norethindrone International Ltd.
acetate) Tablets, c/o AbbVie Inc., 1
0.02 mg/1 mg. N Waukegan Rd.,
North Chicago, IL
60064.
NDA 204427.................. Kerydin (tavabarole) Anacor
Topical Solution, Pharmaceuticals
5%. Inc., 445 Eastern
Point Rd., Groton,
CT 06340.
NDA 205103.................. Yosprala (aspirin/ Genus Lifesciences
omeprazole) Delayed- Inc., 514 North
Release Tablets, 81 12th St.,
mg/40 mg and 325 mg/ Allentown, PA
40 mg. 18102.
NDA 205383.................. Oraltag (iohexol) Interpharma Praha AS
for Oral Solution, c/o Otsuka
9.7 gram/bottle. Pharmaceutical
Development and
Commercialization
Inc., 508 Carnegie
Center Dr.,
Princeton, NJ
08540.
NDA 207930.................. Utibron Novartis
(glycopyrrolate, Pharmaceuticals
indacaterol Corp.
maleate) Inhalation
Powder, 15.6
microgram/inhaler
and 27.5 microgram/
inhaler.
NDA 207923.................. Seebri Neohaler Do.
(glycopyrrolate)
Inhalation Powder,
15.6 microgram/
inhaler.
NDA 216951.................. Jesduvroq GlaxoSmithKline
(daprodustat) Intellectual
Tablets, 1 mg, 2 Property (No. 2)
mg, 4 mg, 6 mg, and Ltd. England
8 mg. c/o GSK, 2929
Walnut St., Suite
1700, Philadelphia,
PA 19104.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of December
19, 2024. Approval of each entire application is withdrawn, including
any strengths and dosage forms included in the application but
inadvertently missing from table 1. Introduction or delivery for
introduction into interstate commerce of products listed in table 1
without an approved NDA violates sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Drug products that
[[Page 91412]]
are listed in table 1 that are in inventory on December 19, 2024 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 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26913 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P
