Determination That ARALEN (Chloroquine Phosphate) Oral Tablets, 500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 1516-1517 [2021-00118]
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1516
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
(HCl), dopamine HCl, edetate calcium
disodium, folic acid, glycopyrrolate,
hydroxyzine HCl, ketorolac
tromethamine, labetalol HCl, mannitol,
metoclopramide HCl, moxifloxacin HCl,
nalbuphine HCl, polidocanol, potassium
acetate, procainamide HCl, sodium
nitroprusside, sodium thiosulfate, and
verapamil HCl. Interested persons were
originally given until September 29,
2020, to comment on FDA’s proposals.
During the comment period for the
July 31, 2020, notice, FDA received a
request to allow interested persons
additional time to comment. The
requester asserted that the time period
of 60 days was insufficient to respond
fully to FDA’s specific requests for
comments and noted the commenter’s
obligations to respond to the exigencies
of COVID–19 pandemic.
FDA has considered the request and
other relevant factors, and accordingly
is reopening the comment period for the
July 31, 2020, notice for 30 days, until
February 8, 2021. The Agency believes
that an additional 30 days will allow
adequate time for interested persons to
submit comments.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2021–00123 Filed 1–7–21; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–2300]
Determination That ARALEN
(Chloroquine Phosphate) Oral Tablets,
500 Milligrams, 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Products Were Not Withdrawn From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in this document were not withdrawn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:
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: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
Application
No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 006002
ARALEN ...................
500 milligrams (mg) ...................
Tablet; Oral ...............
NDA 006134
DOLOPHINE HYDROCHLORIDE.
BENTYL ....................
5 mg; 10 mg ...............................
Tablet; Oral ...............
10 mg .........................................
Capsule; Oral ...........
20 mg .........................................
Tablet; Oral.
Equivalent to (EQ) 2.5 mg Base
Tablet; Oral ...............
NDA 008085
Methotrexate Sodium
Chloroquine Phosphate.
Methadone Hydrochloride.
Dicyclomine Hydrochloride.
Dicyclomine Hydrochloride.
Methotrexate Sodium
NDA 008678
NDA 012945
Isoniazid ...................
DIAMOX ...................
Isoniazid ...................
Acetazolamide ..........
100 mg; 300 mg .........................
500 mg .......................................
Tablet; Oral ...............
Extended-Release
Capsule; Oral.
NDA 014103
ONCOVIN .................
Vincristine Sulfate .....
Injectable; Injection ...
NDA 016792
SURMONTIL ............
Trimipramine Maleate
1 mg/milliliter (mL); 1 mg/Vial; 5
mg/Vial.
EQ 25 mg/Base; EQ 50 mg/
Base; EQ 100 mg/Base.
NDA 007409
tkelley on DSKBCP9HB2PROD with NOTICES
Food and Drug Administration
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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,
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.
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Capsule; Oral ...........
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08JAN1
Applicant
Sanofi-Aventis U.S.
LLC.
Hikma Pharmaceuticals PLC.
Allergan Pharmaceuticals.
DAVA Pharmaceuticals, Inc.
Sandoz.
Teva Branded Pharmaceutical Products.
Eli Lilly and Co.
Teva Women’s
Health, Inc.
1517
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
Application
No.
NDA 016801
Drug name
Active ingredient(s)
NDA 018238
XYLOCAINE PRELidocaine HydroSERVATIVE FREE.
chloride.
MICRO–K ................. Potassium Chloride ..
NDA 019568
DERMATOP .............
Prednicarbate ...........
NDA 020192
LAMISIL ....................
NDA 020482
NDA 020591
PRECOSE ................
TARKA ......................
NDA 020635
LEVAQUIN ...............
Terbinafine Hydrochloride.
Acarbose ..................
Trandolapril;
Verapamil Hydrochloride.
Levofloxacin ..............
NDA 020823
EXELON ...................
Rivastigmine Tartrate
NDA 020920
NATRECOR .............
Nesiritide ...................
NDA 021549
NDA 021590
EMEND .....................
FAZACLO ODT ........
Aprepitant .................
Clozapine ..................
NDA 202535
PREPOPIK ...............
Citric Acid, Magnesium Oxide, and
Sodium Picosulfate.
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
NDAs and ANDAs listed are unaffected
by the discontinued marketing of the
products subject to those NDAs and
ANDAs. 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: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
tkelley on DSKBCP9HB2PROD with NOTICES
[FR Doc. 2021–00118 Filed 1–7–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
Strength(s)
Dosage form/route
Applicant
1%; 2%; 4%; 10%; 20% ............
Injectable; Injection ...
8
milliequivalents (mEq); 10
mEq.
0.10% .........................................
Extended-Release
Capsule; Oral.
Ointment; Topical .....
1% ..............................................
Cream; Topical .........
Fresenius Kabi USA,
LLC.
Nesher Pharmaceuticals LLC.
Valeant Pharmaceuticals.
Novartis.
25 mg; 50 mg; 100 mg ..............
1 mg; 240 mg .............................
Tablet; Oral ...............
Extended-Release
Tablet; Oral.
Bayer Healthcare.
AbbVie Inc.
EQ 500 mg/20 mL; EQ 750 mg/
30 mL.
EQ 1.5 mg Base; EQ 3 mg
Base; EQ 4.5 mg Base; EQ 6
mg Base.
1.5 mg/Vial .................................
Injectable; Injection ...
Janssen Pharmaceuticals, Inc.
Novartis.
40 mg .........................................
12.5 mg; 25 mg; 100 mg; 150
mg; and 200 mg.
12 grams (g)/Packet; 3.5 g/
Packet; 10 mg/Packet.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Committee on the National Health
Service Corps
Capsule; Oral ...........
For Solution; Intravenous.
Capsule; Oral ...........
Orally Disintegrating
Tablet; Oral.
For Solution; Oral .....
Scios Inc.
Merck.
Jazz Pharmaceuticals
PLC.
Ferring Pharmaceuticals Inc.
the meeting will be held, visit the
NACNHSC website 30 business days
before the date of the meeting, where
instructions for joining meetings either
in-person or remotely will also be
posted. In-person NACNHSC meetings
will be held at 5600 Fishers Lane,
Rockville, Maryland 20857. For meeting
information updates, go to the
NACNHSC website meeting page at
https://nhsc.hrsa.gov/nac/
meetings.html.
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Committee on the National
Health Service Corps (NACNHSC) will
hold public meetings for the 2021
calendar year (CY). Information about
NACNHSC, agendas, and materials for
these meetings can be found on the
NACNHSC website at https://
nhsc.hrsa.gov/about/national-advisorycouncil-nhsc/.
DATES: NACNHSC meetings will be held
on
• March 16, 2021, 9:00 a.m.–5:00 p.m.
Eastern Time (ET) and March 17, 2021,
9:00 a.m.–2:00 p.m. ET;
• June 22, 2021, 9:00 a.m.–5:00 p.m.
ET and June 23, 2021, 9:00 a.m.–2:00
p.m. ET;
• November 9, 2021, 9:00 a.m.–5: 00
p.m. ET and November 10, 2021, 9:00
a.m.–2:00 p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe
Connect webinar. For updates on how
Diane Fabiyi-King (DFO), Division of
National Health Service Corps, Bureau
of Health Workforce, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–3609; or
NHSCAdvisoryCouncil@hrsa.gov.
SUPPLEMENTARY INFORMATION:
NACNHSC provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning the activities
under Subpart II, Part D of Title III of
the Public Health Service Act (42 U.S.C.
254d–254k). NACNHSC designates areas
of the United States with health
professional shortages and assigns
National Health Service Corps clinicians
to improve the delivery of health
services in health professional shortage
areas. Since priorities dictate meeting
times and agenda items, be advised that
start times, end times, and agenda items
are subject to change. For CY 2021
meetings, agenda items may include,
but are not limited to, the identification
of NACNHSC priorities for future
AGENCY:
SUMMARY:
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08JAN1
]]>Agencies
[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1516-1517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00118]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2300]
Determination That ARALEN (Chloroquine Phosphate) Oral Tablets,
500 Milligrams, 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: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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, 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 006002......................... ARALEN................ Chloroquine Phosphate. 500 milligrams (mg).. Tablet; Oral......... Sanofi-Aventis U.S.
LLC.
NDA 006134......................... DOLOPHINE Methadone 5 mg; 10 mg.......... Tablet; Oral......... Hikma Pharmaceuticals
HYDROCHLORIDE. Hydrochloride. PLC.
NDA 007409......................... BENTYL................ Dicyclomine 10 mg................ Capsule; Oral........ Allergan
Hydrochloride. Pharmaceuticals.
Dicyclomine 20 mg................ Tablet; Oral.........
Hydrochloride.
NDA 008085......................... Methotrexate Sodium... Methotrexate Sodium... Equivalent to (EQ) Tablet; Oral......... DAVA Pharmaceuticals,
2.5 mg Base. Inc.
NDA 008678......................... Isoniazid............. Isoniazid............. 100 mg; 300 mg....... Tablet; Oral......... Sandoz.
NDA 012945......................... DIAMOX................ Acetazolamide......... 500 mg............... Extended-Release Teva Branded
Capsule; Oral. Pharmaceutical
Products.
NDA 014103......................... ONCOVIN............... Vincristine Sulfate... 1 mg/milliliter (mL); Injectable; Injection Eli Lilly and Co.
1 mg/Vial; 5 mg/Vial.
NDA 016792......................... SURMONTIL............. Trimipramine Maleate.. EQ 25 mg/Base; EQ 50 Capsule; Oral........ Teva Women's Health,
mg/Base; EQ 100 mg/ Inc.
Base.
[[Page 1517]]
NDA 016801......................... XYLOCAINE PRESERVATIVE Lidocaine 1%; 2%; 4%; 10%; 20%. Injectable; Injection Fresenius Kabi USA,
FREE. Hydrochloride. LLC.
NDA 018238......................... MICRO-K............... Potassium Chloride.... 8 milliequivalents Extended-Release Nesher
(mEq); 10 mEq. Capsule; Oral. Pharmaceuticals LLC.
NDA 019568......................... DERMATOP.............. Prednicarbate......... 0.10%................ Ointment; Topical.... Valeant
Pharmaceuticals.
NDA 020192......................... LAMISIL............... Terbinafine 1%................... Cream; Topical....... Novartis.
Hydrochloride.
NDA 020482......................... PRECOSE............... Acarbose.............. 25 mg; 50 mg; 100 mg. Tablet; Oral......... Bayer Healthcare.
NDA 020591......................... TARKA................. Trandolapril; 1 mg; 240 mg......... Extended-Release AbbVie Inc.
Verapamil Tablet; Oral.
Hydrochloride.
NDA 020635......................... LEVAQUIN.............. Levofloxacin.......... EQ 500 mg/20 mL; EQ Injectable; Injection Janssen
750 mg/30 mL. Pharmaceuticals,
Inc.
NDA 020823......................... EXELON................ Rivastigmine Tartrate. EQ 1.5 mg Base; EQ 3 Capsule; Oral........ Novartis.
mg Base; EQ 4.5 mg
Base; EQ 6 mg Base.
NDA 020920......................... NATRECOR.............. Nesiritide............ 1.5 mg/Vial.......... For Solution; Scios Inc.
Intravenous.
NDA 021549......................... EMEND................. Aprepitant............ 40 mg................ Capsule; Oral........ Merck.
NDA 021590......................... FAZACLO ODT........... Clozapine............. 12.5 mg; 25 mg; 100 Orally Disintegrating Jazz Pharmaceuticals
mg; 150 mg; and 200 Tablet; Oral. PLC.
mg.
NDA 202535......................... PREPOPIK.............. Citric Acid, Magnesium 12 grams (g)/Packet; For Solution; Oral... Ferring
Oxide, and Sodium 3.5 g/Packet; 10 mg/ Pharmaceuticals Inc.
Picosulfate. Packet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 NDAs and ANDAs listed are
unaffected by the discontinued marketing of the products subject to
those NDAs and ANDAs. 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: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00118 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P
