Determination That NALFON (Fenoprofen Calcium) Oral Capsules, Equivalent to 300 Milligram Base, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 24841-24842 [2024-07494]
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24841
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
SYSTEM NAME AND NUMBER:
Transportation Benefits Records,
GSA/TRANSIT–1.
HISTORY:
[FR Doc. 2024–07504 Filed 4–8–24; 8:45 am]
A SORN was previously published in
the Federal Register at 76 FR 56762 on
October 14, 2011.
BILLING CODE P
GENERAL SERVICES
ADMINISTRATION
[Notice–IE–2024–03; Docket No. 2024–0001;
Sequence No. 9]
Privacy Act of 1974; Rescindment of a
System of Records
[FR Doc. 2024–07430 Filed 4–8–24; 8:45 am]
BILLING CODE 6820–AB–P
Office of the Chief Privacy
Officer; General Services
Administration, (GSA).
ACTION: Rescindment of a system of
records notice.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1569]
Pursuant to the Privacy Act of
1974 and Office of Management and
Budget (OMB) Circular No. A–108,
notice is hereby given that the GSA
proposes to rescind the GSA/Transit–1,
Transportation Benefits Records, System
of Records Notice (SORN). This system
of records contains information entered
by GSA and provides transportation
fringe benefits to employees who use
mass transportation to commute to and
from work.
DATES: Effective immediately.
ADDRESSES: Comments may be
submitted to the Federal eRulemaking
Portal, https://www.regulations.gov.
Submit comments by searching for
Notice–IE–2024–03, GSA/Transit–1.
FOR FURTHER INFORMATION CONTACT: Call
or email Richard Speidel, Chief Privacy
Officer at 202–969–5830 and
gsa.privacyact@gsa.gov.
SUPPLEMENTARY INFORMATION: GSA
proposes to rescind a System of
Records, GSA/Transit–1. This Notice is
being rescinded due to the records of
GSA/Transit–1 being maintained under
DOT/ALL–8, Parking and Transit
Benefit System, managed by the
Department of Transportation (DOT).
The records under GSA/Transit–1 were
transitioned to the DOT in 2017 and are
now being maintained under
DOT/ALL–8.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Richard Speidel,
Chief Privacy Officer, Office of the Deputy
Chief Information Officer, General Services
Administration.
Determination That NALFON
(Fenoprofen Calcium) Oral Capsules,
Equivalent to 300 Milligram Base, and
Other Drug Products 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 or Agency) has
determined that the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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 generally known
as the ‘‘Orange Book.’’ Under FDA
regulations, a drug is removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table are no longer
being marketed.
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 017604 ............
NALFON ...........................
Fenoprofen Calcium .........
Capsule; Oral ...................
Xspire Pharma.
NDA 017087 ............
NDA 018801 ............
Enflurane ..........................
Sterile Water For Injection
Liquid; Inhalation ..............
Liquid; N/A .......................
NDA 019152 ............
ETHRANE ........................
STERILE WATER FOR
INJECTION.
CALAN SR .......................
Equivalent to (EQ) 300
Milligrams (mg) Base.
99.9% ...............................
100% (1 Milliliter (mL));
100% (5.2 mL).
120 mg; 180 mg, 240 mg
Baxter Healthcare Corp.
Hospira, A Pfizer Company.
Pfizer Inc.
NDA 019885 ............
ACCUPRIL .......................
Quinapril Hydrochloride ...
VerDate Sep<11>2014
19:57 Apr 08, 2024
Jkt 262001
Verapamil Hydrochloride ..
PO 00000
Frm 00066
EQ 5 mg Base; EQ 10 mg
Base; EQ 20 mg Base;
EQ 40 mg Base.
Fmt 4703
Sfmt 4703
Tablet, Extended Release;
Oral.
Tablet; Oral ......................
E:\FR\FM\09APN1.SGM
09APN1
Applicant
Pfizer Pharmaceuticals
Ltd.
ddrumheller on DSK120RN23PROD with NOTICES1
24842
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
Applicant
NDA 019941 ............
EMLA ...............................
Lidocaine; Prilocaine ........
2.5%; 2.5% .......................
Cream; Topical .................
NDA 020105 ............
NDA 020125 ............
TRIOSTAT .......................
ACCURETIC ....................
Liothyronine Sodium ........
Hydrochlorothiazide;
Quinapril Hydrochloride.
Injectable; Injection ..........
Tablet; Oral ......................
NDA 020406 ............
PREVACID .......................
Lansoprazole ....................
EQ 0.01 mg Base/mL ......
12.5 mg, EQ 10 mg Base;
12.5 mg, EQ 20 mg
Base; 25 mg, EQ 20
mg Base.
15 mg ...............................
Teva Branded Pharmaceutical Products R & D
Inc.
Par Sterile Products, LLC.
Pfizer Pharmaceuticals
Ltd.
NDA
NDA
NDA
NDA
............
............
............
............
ALBENZA .........................
ALDARA ...........................
SUSTIVA ..........................
ALOCRIL ..........................
Albendazole .....................
Imiquimod .........................
Efavirenz ..........................
Nedocromil Sodium ..........
200 mg .............................
5% ....................................
50 mg; 200 mg .................
2% ....................................
NDA 021526 ............
RANEXA ..........................
Ranolazine .......................
500 mg; 1 g ......................
NDA 021565 ............
ELESTAT .........................
Epinastine Hydrochloride
0.05% ...............................
NDA 021775 ............
ENTEREG ........................
Alvimopan ........................
12 mg ...............................
Solution/Drops; Ophthalmic.
Capsule; Oral ...................
NDA 021790 ............
DACOGEN .......................
Decitabine ........................
50 mg/Vial ........................
Injectable; Intravenous .....
NDA 050095 ............
NDA 050795 ............
CAPASTAT SULFATE .....
DORYX ............................
Capreomycin Sulfate ........
Doxycycline Hyclate .........
Injectable; Injection ..........
Tablet, Delayed Release;
Oral.
NDA 050801 ............
EVOCLIN .........................
Clindamycin Phosphate ...
EQ 1 g Base/Vial .............
EQ 50 mg Base; EQ 100
mg Base; EQ 120 mg
Base.
1% ....................................
NDA 200179 ............
STAXYN ...........................
Vardenafil Hydrochloride ..
10 mg ...............................
NDA 202515 ............
MORPHINE SULFATE ....
Morphine Sulfate ..............
15 mg/mL .........................
Tablet, Orally Disintegrating; Oral.
Injectable; Injection ..........
NDA 203667 ............
MINASTRIN 24 FE ..........
0.02mg, 1mg ....................
Tablet; Oral ......................
NDA 210854 ............
XOFLUZA .........................
Ethinyl Estradiol;
Norethindrone Acetate.
Baloxavir Marboxil ............
20 mg ...............................
Tablet; Oral ......................
020666
020723
020972
021009
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list the drug
products in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
drug products listed are unaffected by
the discontinued marketing of the
products subject to these applications.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–07494 Filed 4–8–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:57 Apr 08, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1875]
Financial Transparency and Efficiency
of the Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic
Drug User Fee Amendments; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the following public
meeting entitled ‘‘Financial
Transparency and Efficiency of the
Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic
Drug User Fee Amendments.’’ The topic
to be discussed is the financial
transparency and efficiency of the
Prescription Drug User Fee Act,
Biosimilar User Fee Act, and Generic
Drug User Fee Amendments.
DATES: The public meeting will be held
on June 6, 2024, from 9:30 a.m. to 10:40
a.m. via ZoomGov. Either electronic or
written comments on this public
meeting must be submitted by July 6,
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Capsule, Delayed Release Pellets; Oral.
Tablet; Oral ......................
Cream; Topical .................
Capsule; Oral ...................
Solution/Drops; Ophthalmic.
Tablet, Extended Release;
Oral.
Aerosol, Foam; Topical ....
Takeda Pharmaceuticals
USA, Inc.
Impax Laboratories Inc.
Bausch Health US LLC.
Bristol Myers Squibb Co.
Allergan Inc.
Menarini International Operations Luxembourg
SA.
Allergan Inc.
Cubist Pharmaceuticals,
Inc.
Otsuka Pharmaceutical
Co., Ltd.
Epic Pharma, LLC.
Mayne Pharma International Pty Ltd.
Mylan Pharmaceuticals
Inc.
Bayer Healthcare Pharmaceuticals Inc.
Hospira, A Pfizer Company.
Allergan Pharmaceuticals
International, Ltd.
Genentech, Inc.
2024. See the SUPPLEMENTARY
section for registration date
and information.
ADDRESSES: The public meeting will be
held virtually due to extenuating
circumstances.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 6, 2024. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are received
on or before that date.
INFORMATION
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
E:\FR\FM\09APN1.SGM
09APN1
Agencies
[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24841-24842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07494]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1569]
Determination That NALFON (Fenoprofen Calcium) Oral Capsules,
Equivalent to 300 Milligram Base, and Other Drug Products Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[email protected].
SUPPLEMENTARY INFORMATION: 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
generally known as the ``Orange Book.'' Under FDA regulations, a drug
is removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table are
no longer being marketed.
----------------------------------------------------------------------------------------------------------------
Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 017604............. NALFON.......... Fenoprofen Equivalent to Capsule; Oral... Xspire Pharma.
Calcium. (EQ) 300
Milligrams (mg)
Base.
NDA 017087............. ETHRANE......... Enflurane....... 99.9%........... Liquid; Baxter
Inhalation. Healthcare
Corp.
NDA 018801............. STERILE WATER Sterile Water 100% (1 Liquid; N/A..... Hospira, A
FOR INJECTION. For Injection. Milliliter Pfizer
(mL)); 100% Company.
(5.2 mL).
NDA 019152............. CALAN SR........ Verapamil 120 mg; 180 mg, Tablet, Extended Pfizer Inc.
Hydrochloride. 240 mg. Release; Oral.
NDA 019885............. ACCUPRIL........ Quinapril EQ 5 mg Base; EQ Tablet; Oral.... Pfizer
Hydrochloride. 10 mg Base; EQ Pharmaceutical
20 mg Base; EQ s Ltd.
40 mg Base.
[[Page 24842]]
NDA 019941............. EMLA............ Lidocaine; 2.5%; 2.5%...... Cream; Topical.. Teva Branded
Prilocaine. Pharmaceutical
Products R & D
Inc.
NDA 020105............. TRIOSTAT........ Liothyronine EQ 0.01 mg Base/ Injectable; Par Sterile
Sodium. mL. Injection. Products, LLC.
NDA 020125............. ACCURETIC....... Hydrochlorothiaz 12.5 mg, EQ 10 Tablet; Oral.... Pfizer
ide; Quinapril mg Base; 12.5 Pharmaceutical
Hydrochloride. mg, EQ 20 mg s Ltd.
Base; 25 mg, EQ
20 mg Base.
NDA 020406............. PREVACID........ Lansoprazole.... 15 mg........... Capsule, Delayed Takeda
Release Pharmaceutical
Pellets; Oral. s USA, Inc.
NDA 020666............. ALBENZA......... Albendazole..... 200 mg.......... Tablet; Oral.... Impax
Laboratories
Inc.
NDA 020723............. ALDARA.......... Imiquimod....... 5%.............. Cream; Topical.. Bausch Health
US LLC.
NDA 020972............. SUSTIVA......... Efavirenz....... 50 mg; 200 mg... Capsule; Oral... Bristol Myers
Squibb Co.
NDA 021009............. ALOCRIL......... Nedocromil 2%.............. Solution/Drops; Allergan Inc.
Sodium. Ophthalmic.
NDA 021526............. RANEXA.......... Ranolazine...... 500 mg; 1 g..... Tablet, Extended Menarini
Release; Oral. International
Operations
Luxembourg SA.
NDA 021565............. ELESTAT......... Epinastine 0.05%........... Solution/Drops; Allergan Inc.
Hydrochloride. Ophthalmic.
NDA 021775............. ENTEREG......... Alvimopan....... 12 mg........... Capsule; Oral... Cubist
Pharmaceutical
s, Inc.
NDA 021790............. DACOGEN......... Decitabine...... 50 mg/Vial...... Injectable; Otsuka
Intravenous. Pharmaceutical
Co., Ltd.
NDA 050095............. CAPASTAT SULFATE Capreomycin EQ 1 g Base/Vial Injectable; Epic Pharma,
Sulfate. Injection. LLC.
NDA 050795............. DORYX........... Doxycycline EQ 50 mg Base; Tablet, Delayed Mayne Pharma
Hyclate. EQ 100 mg Base; Release; Oral. International
EQ 120 mg Base. Pty Ltd.
NDA 050801............. EVOCLIN......... Clindamycin 1%.............. Aerosol, Foam; Mylan
Phosphate. Topical. Pharmaceutical
s Inc.
NDA 200179............. STAXYN.......... Vardenafil 10 mg........... Tablet, Orally Bayer
Hydrochloride. Disintegrating; Healthcare
Oral. Pharmaceutical
s Inc.
NDA 202515............. MORPHINE SULFATE Morphine Sulfate 15 mg/mL........ Injectable; Hospira, A
Injection. Pfizer
Company.
NDA 203667............. MINASTRIN 24 FE. Ethinyl 0.02mg, 1mg..... Tablet; Oral.... Allergan
Estradiol; Pharmaceutical
Norethindrone s
Acetate. International,
Ltd.
NDA 210854............. XOFLUZA......... Baloxavir 20 mg........... Tablet; Oral.... Genentech, Inc.
Marboxil.
----------------------------------------------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
Approved ANDAs that refer to the drug products listed are
unaffected by the discontinued marketing of the products subject to
these applications. Additional ANDAs that refer to these products may
also be approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07494 Filed 4-8-24; 8:45 am]
BILLING CODE 4164-01-P