Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 96654-96655 [2024-28433]
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Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices
(PDPs), and Programs of All-Inclusive
Care for the Elderly (PACE)
organizations report financial
information demonstrating the
organization has a fiscally sound
operation. The FSRR is designed to
capture financial data of these
contracting entities. The Division of
Finance and Benefits (DFB) within the
Medicare Advantage Contract
Administration Group (MCAG) of CMS
is assigned the responsibility of
reviewing ongoing financial
performance of the contracting entities.
All contracting organizations must
submit audited annual financial
statements one time per year. In
addition to the audited annual
submission, Health Plans with a
negative net worth and/or a net loss and
the amount of that loss is greater than
one-half of the organization’s total net
worth submit quarterly financial
statements for fiscal soundness
monitoring. Part D organizations are
required to submit three (3) quarterly
financial statements. Lastly, PACE
organizations are required to file four (4)
quarterly financial statements for the
first three (3) years in the program. After
the first three (3) years, PACE
organizations with a negative net worth
and/or a net loss and the amount of that
loss is greater than one-half of the
organization’s total net worth must
submit quarterly financial statements for
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Number: CMS–906 (OMB control
number: 0938–0496); Frequency:
Quarterly and Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 251; Total
Annual Responses: 1,004; Total Annual
Hours: 335. (For policy questions
regarding this collection contact Christa
M. Zalewski at (410) 786–1971.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–28458 Filed 12–4–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5354]
Determination That Bentyl Preservative
Free (Dicyclomine Hydrochloride)
Injection, 10 Milligrams/Milliliters, 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.
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
SUMMARY:
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.
TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS
Application No.
Drug name
Active ingredient(s)
Dosage form/route
Strength(s)
NDA 008370 ............
BENTYL PRESERVATIVE
FREE.
KENALOG ........................
Dicyclomine Hydrochloride
Injectable; Injection ..........
Triamcinolone Acetonide
Spray; Topical ..................
10 Milligrams (mg)/Milliliters (mL).
0.147 mg/Gram (g) ..........
Thallous Chloride TL–201
Injectable; Intravenous .....
NDA 017823 ............
THALLOUS CHLORIDE
TL 201.
HALOG .............................
Halcinonide ......................
Solution; Topical ..............
NDA 018849 ............
NDA 020551 ............
LIDEX ...............................
NIMBEX ...........................
Fluocinonide .....................
Cisatracurium Besylate ....
Solution; Topical ..............
Injectable; Injection ..........
NDA 020551 ............
NIMBEX PRESERVATIVE
FREE.
Cisatracurium Besylate ....
Injectable; Injection ..........
khammond on DSK9W7S144PROD with NOTICES
NDA 012104 ............
NDA 017806 ............
VerDate Sep<11>2014
16:31 Dec 04, 2024
Jkt 265001
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
1 Millicurie (mCi)/mL; 2
mCi/mL.
0.10% ...............................
0.05% ...............................
Equivalent to (EQ) 2 mg
Base/mL.
EQ 2 mg Base/mL; EQ 10
mg Base/mL.
E:\FR\FM\05DEN1.SGM
05DEN1
Applicant
AbbVie.
Sun Pharmaceutical Industries Limited.
Lantheus.
Sun Pharmaceutical Industries Limited.
Alvogen.
AbbVie.
AbbVie.
96655
Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices
khammond on DSK9W7S144PROD with NOTICES
TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS—Continued
Application No.
Drug name
Dosage form/route
Strength(s)
NDA 020837 ............
XOPENEX ........................
Levalbuterol Hydrochloride.
Solution; Inhalation ..........
NDA 020857 ............
NDA 020977 ............
NDA 021205 ............
COMBIVIR .......................
ZIAGEN ............................
TRIZIVIR ..........................
Tablet; Oral ......................
Tablet; Oral ......................
Tablet; Oral ......................
NDA 021223 ............
ZOMETA ..........................
Lamivudine; Zidovudine ...
Abacavir Sulfate ...............
Abacavir Sulfate,
Lamivudine, Zidovudine.
Zoledronic Acid ................
NDA
NDA
NDA
NDA
NDA
NDA
............
............
............
............
............
............
LEXIVA .............................
ANTARA (MICRONIZED)
EXTINA ............................
PATANASE ......................
SELZENTRY ....................
ONGLYZA ........................
Fosamprenavir Calcium ...
Fenofibrate .......................
Ketoconazole ...................
Olopatadine Hydrochloride
Maraviroc .........................
Saxagliptin Hydrochloride
Tablet; Oral ......................
Capsule; Oral ...................
Aerosol, Foam; Topical ....
Spray, Metered; Nasal .....
Tablet; Oral ......................
Tablet; Oral ......................
NDA 050440 ............
KEFLET ............................
Cephalexin .......................
Tablet; Oral ......................
NDA 050558 ............
ZINACEF ..........................
Cefuroxime Sodium .........
Injectable; Intramuscular,
Intravenous.
NDA 050567 ............
POLYTRIM .......................
NDA 050588 ............
NDA 050795 ............
CEFOTAN ........................
DORYX ............................
Polymyxin B Sulfate,
Trimethoprim Sulfate.
Cefotetan Disodium .........
Doxycycline Hyclate .........
NDA 200678 ............
KOMBIGLYZE XR ............
Solution/Drops; Ophthalmic.
Injectable; Injection ..........
Tablet, Delayed Release;
Oral.
Tablet, Extended Release;
Oral.
NDA 201194 ............
NDA 204427 ............
OXYCODONE HYDROCHLORIDE.
KERYDIN .........................
NDA 204592 ............
NDA 204790 ............
NDA 215868 ............
021548
021695
021738
021861
022128
022350
Active ingredient(s)
Metformin Hydrochloride,
Saxagliptin Hydrochloride.
Oxycodone Hydrochloride
Solution; Oral ...................
EQ 0.0103% Base; EQ
0.021% Base; EQ
0.042% Base; EQ
0.25% Base.
150 mg; 300 mg ...............
EQ 300 mg Base .............
EQ 300 mg Base, 150
mg, 300 mg.
EQ 4 mg Base/100 mL;
EQ 4 mg Base/5 mL.
EQ 700 mg Base .............
90 mg ...............................
2% ....................................
0.665 mg/Spray ................
25 mg; 75 mg ...................
EQ 2.5 mg Base; EQ 5
mg Base.
EQ 250 mg Base; EQ 500
mg Base.
EQ 750 mg Base/Vial; EQ
1.5 g Base/Vial; EQ 7.5
g Base/Vial.
10,000 Units/mL, EQ 1
mg Base/mL.
EQ 10 g Base/Vial ...........
EQ 75 mg Base; EQ 150
mg Base.
500 mg, EQ 5 mg Base; 1
g, EQ 5 mg Base; 1 g,
EQ 2.5 mg Base.
5 mg/5 mL ........................
Tavaborole .......................
Solution; Topical ..............
5% ....................................
ZORVOLEX ......................
TIVICAY ...........................
Diclofenac ........................
Dolutegravir Sodium ........
Capsule; Oral ...................
Tablet; Oral ......................
MIDAZOLAM IN 0.8%
SODIUM CHLORIDE.
Midazolam ........................
Solution; Intravenous .......
35 mg ...............................
EQ 10 mg Base; EQ 25
mg Base.
50 mg/50 mL (1 mg/mL) ..
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.
VerDate Sep<11>2014
16:31 Dec 04, 2024
Jkt 265001
Injectable; Intravenous .....
Dated: November 27, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–28433 Filed 12–4–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0604]
Yong Sheng Jiao; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
denying a request for a hearing
submitted by Yong Sheng Jiao, also
known as Yongsheng Jiao and Wilson
Jiao (Jiao), and is issuing an order under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) debarring Jiao for 5
years from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
SUMMARY:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Applicant
Hikma.
Viiv Health Care.
Viiv Health Care.
Viiv Health Care.
Novartis.
Viiv Health Care.
Lupin.
Mylan.
Novartis.
Viiv Health Care.
AstraZeneca AB.
Eli Lilly and Company.
PAI Pharma.
Allergan.
PAI Pharma.
Mayne Pharma.
AstraZeneca AB.
VistaPharm, LLC.
Anacor Pharmaceuticals,
Inc.
Zyla.
Viiv Health Care.
Exela Pharma.
finding that Jiao was convicted of a
felony under Federal law for conduct
relating to the importation into the
United States of any drug or controlled
substance under the FD&C Act. In
determining the appropriateness and
period of Jiao’s debarment, FDA
considered the relevant factors listed in
the FD&C Act. Jiao submitted a request
for hearing but failed to file with the
Agency information and analyses
sufficient to create a basis for a hearing.
DATES: The order is applicable
December 5, 2024.
ADDRESSES: Any application for
termination of debarment by Jiao under
section 306(d) of the FD&C Act (21
U.S.C. 335a(d)) (application) may be
submitted as follows:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
E:\FR\FM\05DEN1.SGM
05DEN1
]]>Agencies
[Federal Register Volume 89, Number 234 (Thursday, December 5, 2024)]
[Notices]
[Pages 96654-96655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28433]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5354]
Determination That Bentyl Preservative Free (Dicyclomine
Hydrochloride) Injection, 10 Milligrams/Milliliters, 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.
Table 1--Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness
----------------------------------------------------------------------------------------------------------------
Active Dosage form/
Application No. Drug name ingredient(s) route Strength(s) Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008370............. BENTYL Dicyclomine Injectable; 10 Milligrams AbbVie.
PRESERVATIVE Hydrochloride. Injection. (mg)/
FREE. Milliliters
(mL).
NDA 012104............. KENALOG......... Triamcinolone Spray; Topical.. 0.147 mg/Gram Sun
Acetonide. (g). Pharmaceutical
Industries
Limited.
NDA 017806............. THALLOUS Thallous Injectable; 1 Millicurie Lantheus.
CHLORIDE TL 201. Chloride TL-201. Intravenous. (mCi)/mL; 2 mCi/
mL.
NDA 017823............. HALOG........... Halcinonide..... Solution; 0.10%........... Sun
Topical. Pharmaceutical
Industries
Limited.
NDA 018849............. LIDEX........... Fluocinonide.... Solution; 0.05%........... Alvogen.
Topical.
NDA 020551............. NIMBEX.......... Cisatracurium Injectable; Equivalent to AbbVie.
Besylate. Injection. (EQ) 2 mg Base/
mL.
NDA 020551............. NIMBEX Cisatracurium Injectable; EQ 2 mg Base/mL; AbbVie.
PRESERVATIVE Besylate. Injection. EQ 10 mg Base/
FREE. mL.
[[Page 96655]]
NDA 020837............. XOPENEX......... Levalbuterol Solution; EQ 0.0103% Base; Hikma.
Hydrochloride. Inhalation. EQ 0.021% Base;
EQ 0.042% Base;
EQ 0.25% Base.
NDA 020857............. COMBIVIR........ Lamivudine; Tablet; Oral.... 150 mg; 300 mg.. Viiv Health
Zidovudine. Care.
NDA 020977............. ZIAGEN.......... Abacavir Sulfate Tablet; Oral.... EQ 300 mg Base.. Viiv Health
Care.
NDA 021205............. TRIZIVIR........ Abacavir Tablet; Oral.... EQ 300 mg Base, Viiv Health
Sulfate, 150 mg, 300 mg. Care.
Lamivudine,
Zidovudine.
NDA 021223............. ZOMETA.......... Zoledronic Acid. Injectable; EQ 4 mg Base/100 Novartis.
Intravenous. mL; EQ 4 mg
Base/5 mL.
NDA 021548............. LEXIVA.......... Fosamprenavir Tablet; Oral.... EQ 700 mg Base.. Viiv Health
Calcium. Care.
NDA 021695............. ANTARA Fenofibrate..... Capsule; Oral... 90 mg........... Lupin.
(MICRONIZED).
NDA 021738............. EXTINA.......... Ketoconazole.... Aerosol, Foam; 2%.............. Mylan.
Topical.
NDA 021861............. PATANASE........ Olopatadine Spray, Metered; 0.665 mg/Spray.. Novartis.
Hydrochloride. Nasal.
NDA 022128............. SELZENTRY....... Maraviroc....... Tablet; Oral.... 25 mg; 75 mg.... Viiv Health
Care.
NDA 022350............. ONGLYZA......... Saxagliptin Tablet; Oral.... EQ 2.5 mg Base; AstraZeneca AB.
Hydrochloride. EQ 5 mg Base.
NDA 050440............. KEFLET.......... Cephalexin...... Tablet; Oral.... EQ 250 mg Base; Eli Lilly and
EQ 500 mg Base. Company.
NDA 050558............. ZINACEF......... Cefuroxime Injectable; EQ 750 mg Base/ PAI Pharma.
Sodium. Intramuscular, Vial; EQ 1.5 g
Intravenous. Base/Vial; EQ
7.5 g Base/Vial.
NDA 050567............. POLYTRIM........ Polymyxin B Solution/Drops; 10,000 Units/mL, Allergan.
Sulfate, Ophthalmic. EQ 1 mg Base/mL.
Trimethoprim
Sulfate.
NDA 050588............. CEFOTAN......... Cefotetan Injectable; EQ 10 g Base/ PAI Pharma.
Disodium. Injection. Vial.
NDA 050795............. DORYX........... Doxycycline Tablet, Delayed EQ 75 mg Base; Mayne Pharma.
Hyclate. Release; Oral. EQ 150 mg Base.
NDA 200678............. KOMBIGLYZE XR... Metformin Tablet, Extended 500 mg, EQ 5 mg AstraZeneca AB.
Hydrochloride, Release; Oral. Base; 1 g, EQ 5
Saxagliptin mg Base; 1 g,
Hydrochloride. EQ 2.5 mg Base.
NDA 201194............. OXYCODONE Oxycodone Solution; Oral.. 5 mg/5 mL....... VistaPharm,
HYDROCHLORIDE. Hydrochloride. LLC.
NDA 204427............. KERYDIN......... Tavaborole...... Solution; 5%.............. Anacor
Topical. Pharmaceutical
s, Inc.
NDA 204592............. ZORVOLEX........ Diclofenac...... Capsule; Oral... 35 mg........... Zyla.
NDA 204790............. TIVICAY......... Dolutegravir Tablet; Oral.... EQ 10 mg Base; Viiv Health
Sodium. EQ 25 mg Base. Care.
NDA 215868............. MIDAZOLAM IN Midazolam....... Solution; 50 mg/50 mL (1 Exela Pharma.
0.8% SODIUM Intravenous. mg/mL).
CHLORIDE.
----------------------------------------------------------------------------------------------------------------
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: November 27, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28433 Filed 12-4-24; 8:45 am]
BILLING CODE 4164-01-P
