Determination That Folic Acid, Oral Tablets, 1 Milligram, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 15682-15683 [2021-06059]
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Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices
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has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
khammond on DSKJM1Z7X2PROD with NOTICES
*1. FDA, Guidance for Industry, ‘‘Interim
Policy on Compounding Using Bulk
Drug Substances Under Section 503B of
the Federal Food, Drug, and Cosmetic
Act,’’ January 2017 (available at https://
www.fda.gov/media/94402/download).
*2. FDA, Guidance for Industry, ‘‘Evaluation
of Bulk Drug Substances Nominated for
Use in Compounding Under Section
503B of the Federal Food, Drug, and
Cosmetic Act,’’ March 2019 (available at
https://www.fda.gov/media/121315/
download).
*3. FDA Memorandum to File, ‘‘Clinical
Need for Quinacrine Hydrochloride in
Compounding Under Section 503B of the
FD&C Act,’’ January 2021.
4. Colombo, R., L. Rocchini, N. Suardi, F.
Benigni, et al., 2012, ‘‘Neoadjuvant
Short-Term Intensive Intravesical
Mitomycin C Regimen Compared with
Weekly Schedule For Low-Grade
Recurrent Non-Muscle-Invasive Bladder
Cancer: Preliminary Results of a
Randomised Phase 2 Study,’’ European
Urology, 62: 797–802.
5. Au, J. L., R. A. Badalament, M. G. Wientjes,
D. C. Young, et al., and International
Mitomycin-C Consortium, 2001.
‘‘Methods to Improve Efficacy of
Intravesical Mitomycin C: Results of a
Randomized Phase III Trial,’’ Journal of
the National Cancer Institute, 93: 597–
604.
6. McHenry, A. R., M. F. Wempe, and P. J.
Rice, 2017, ‘‘Stability of
Extemporaneously Prepared
Hydroxychloroquine Sulfate 25-mg/mL
Suspensions in Plastic Bottles and
Syringes,’’ International Journal of
Pharmaceutical Compounding, 21(3),
251–254 (APA). Retrieved from https://
ijpc.com/Abstracts/
Abstract.cfm?ABS=4322.
7. American Society of Hospital Pharmacists
(ASHP 2020), ’’ Hydroxychloroquine
Sulfate Suspension 25 mg/mL.’’
Retrieved from www.ashp.org.
8. USP 2020, ‘‘USP Draft Compounded
Preparation Monograph for
Hydroxychloroquine Sulfate
Compounded Oral Suspension.’’
Published for public comment in
Pharmacopeial Forum 46(2). Retrieved
Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06060 Filed 3–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0279]
Determination That Folic Acid, Oral
Tablets, 1 Milligram, 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: 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
SUMMARY:
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 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
Applicant
NDA 006135 ...
NDA 016131 ...
Folic Acid .....................
CLOMID ......................
Folic Acid ....................
Clomiphene Citrate .....
1 milligram (mg) ..........
50 mg ..........................
Tablet; Oral .................
Tablet; Oral .................
NDA 016419 ...
Propanolol Hydrochloride.
Pimozide .....................
1 mg/milliliter (mL) .......
Injectable; Injection .....
NDA 017473 ...
Propranolol Hydrochloride.
ORAP ..........................
1 mg; 2 mg ..................
Tablet; Oral .................
NDA 019916 ...
NDA 019967 ...
Morphine Sulfate .........
ULTRAVATE ...............
Morphine Sulfate .........
Halobetasol Propionate
1 mg/mL; 5 mg/mL ......
0.05% ..........................
Injectable; Injection .....
Cream; Topical ............
NDA 020647 ...
ELDEPRYL .................
5 mg ............................
Capsule; Oral ..............
NDA 020925 ...
TAVIST–1 ....................
Selegiline Hydrochloride.
Clemastine Fumarate ..
Eli Lilly & Co.
Sanofi-Aventis U.S.
LLC.
Baxter Healthcare
Corp.
Teva Pharms., USA,
Inc.
ICU Medical, Inc.
Sun Pharmaceutical Industries, Inc.
Somerset Pharms., Inc.
1.34 mg .......................
Tablet; Oral .................
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16:30 Mar 23, 2021
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GlaxoSmithKline Consumer Healthcare.
15683
Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 021015 ...
ANDROGEL ................
Testosterone ...............
NDA 021204 ...
STARLIX .....................
Nateglinide ..................
12.5 mg/1.25 g Actuation.
60 mg; 120 mg ............
Gel, Metered;
Transdermal.
Tablets; Oral ................
NDA 021217 ...
EXALGO .....................
NDA 021365 ...
LEXAPRO ...................
Hydromorphone Hydrochloride.
Escitalopram Oxalate ..
Tablet, Extended-Release; Oral.
Solution; Oral ..............
NDA 021490 ...
FEMCON FE ...............
8 mg; 12 mg; 16 mg;
32 mg.
Equal to (EQ) 5 mg
Base/5 mL.
0.035 mg; 0.4 mg ........
NDA 021860 ...
SARAFEM ...................
EQ 15 mg Base ..........
Tablet; Oral .................
NDA 021870 ...
Fludeoxyglucose F–18
20–200 Millicurie/mL ...
Injectable; Intravenous
NDA 022442 ...
REZIRA .......................
5 mg/5 mL; 60 mg/5
mL.
Solution; Oral ..............
Allergan Pharms.,
International, Ltd.
Allergan Pharms. International, Ltd.
Feinstein Institute Medical Research.
Persion Pharms., LLC.
NDA 050757 ...
PREVPAC ...................
500 mg; 500 mg; 30
mg.
Capsule, Tablet, Capsule; Oral.
Takeda Pharms. USA,
Inc.
NDA 203195 ...
NDA 207931 ...
SUPRAX .....................
TECHNIVIE .................
400 mg ........................
12.5 mg; 75 mg; 50 mg
Capsule; Oral ..............
Tablet; Oral .................
Lupin, Ltd.
AbbVie Inc.
NDA 208624 ...
VIEKIRA XR ................
EQ 200 mg Base; 8.33
mg; 50 mg; 33.33
mg.
Tablet, Extended Release; Oral.
AbbVie Inc.
Ethinyl Estradiol;
Norethindrone.
Fluoxetine Hydrochloride.
Fludeoxyglucose F–18
Hydrocodone
Bitartrate;
Pseudoephedrine
Hydrochloride.
Amoxicillin;
Clarithromycin;
Lansoprazole.
Cefixime ......................
Ombitasvir;
Paritaprevir;
Ritonavir.
Dasabuvir Sodium;
Ombitasvir;
Paritaprevir;
Ritonavir.
khammond on DSKJM1Z7X2PROD with NOTICES
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 listed are unaffected by the
discontinued marketing of the products
subject to those NDAs. 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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06059 Filed 3–23–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:30 Mar 23, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6644]
Fiscal Year 2021 Generic Drug Science
and Research Initiatives Workshop;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘FY 2021 Generic
Drug Science and Research Initiatives
Workshop.’’ The purpose of the public
workshop is to provide an overview of
the status of science and research
initiatives for generic drugs and an
opportunity for public input on these
initiatives. FDA is seeking this input
from a variety of stakeholders—
industry, academia, patient advocates,
professional societies, and other
interested parties—as it fulfills its
commitment under the Generic Drug
User Fee Amendments of 2017 (GDUFA
II) to develop an annual list of science
and research initiatives specific to
generic drugs. FDA will take the
information it obtains from the public
workshop into account in developing its
SUMMARY:
PO 00000
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Tablet, Chewable; Oral
Applicant
AbbVie Inc.
Novartis Pharms.,
Corp.
Specgx, LLC.
Allergan Sales, LLC.
Fiscal Year (FY) 2022 GDUFA science
and research initiatives.
DATES: The public workshop will be
held on June 23, 2021, from 8:30 a.m.
to 4:30 p.m. Eastern Time. Submit either
electronic or written comments on this
public workshop by July 23, 2021. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will
be held virtually.
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 July 23, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 23, 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.
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
E:\FR\FM\24MRN1.SGM
24MRN1
]]>Agencies
[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15682-15683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0279]
Determination That Folic Acid, Oral Tablets, 1 Milligram, 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 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 006135.......... Folic Acid....... Folic Acid....... 1 milligram (mg) Tablet; Oral.... Eli Lilly & Co.
NDA 016131.......... CLOMID........... Clomiphene 50 mg........... Tablet; Oral.... Sanofi-Aventis
Citrate. U.S. LLC.
NDA 016419.......... Propranolol Propanolol 1 mg/milliliter Injectable; Baxter
Hydrochloride. Hydrochloride. (mL). Injection. Healthcare
Corp.
NDA 017473.......... ORAP............. Pimozide......... 1 mg; 2 mg...... Tablet; Oral.... Teva Pharms.,
USA, Inc.
NDA 019916.......... Morphine Sulfate. Morphine Sulfate. 1 mg/mL; 5 mg/mL Injectable; ICU Medical,
Injection. Inc.
NDA 019967.......... ULTRAVATE........ Halobetasol 0.05%........... Cream; Topical.. Sun
Propionate. Pharmaceutical
Industries,
Inc.
NDA 020647.......... ELDEPRYL......... Selegiline 5 mg............ Capsule; Oral... Somerset
Hydrochloride. Pharms., Inc.
NDA 020925.......... TAVIST-1......... Clemastine 1.34 mg......... Tablet; Oral.... GlaxoSmithKline
Fumarate. Consumer
Healthcare.
[[Page 15683]]
NDA 021015.......... ANDROGEL......... Testosterone..... 12.5 mg/1.25 g Gel, Metered; AbbVie Inc.
Actuation. Transdermal.
NDA 021204.......... STARLIX.......... Nateglinide...... 60 mg; 120 mg... Tablets; Oral... Novartis
Pharms., Corp.
NDA 021217.......... EXALGO........... Hydromorphone 8 mg; 12 mg; 16 Tablet, Extended- Specgx, LLC.
Hydrochloride. mg; 32 mg. Release; Oral.
NDA 021365.......... LEXAPRO.......... Escitalopram Equal to (EQ) 5 Solution; Oral.. Allergan Sales,
Oxalate. mg Base/5 mL. LLC.
NDA 021490.......... FEMCON FE........ Ethinyl 0.035 mg; 0.4 mg Tablet, Allergan
Estradiol; Chewable; Oral. Pharms.,
Norethindrone. International,
Ltd.
NDA 021860.......... SARAFEM.......... Fluoxetine EQ 15 mg Base... Tablet; Oral.... Allergan Pharms.
Hydrochloride. International,
Ltd.
NDA 021870.......... Fludeoxyglucose F- Fludeoxyglucose F- 20-200 Injectable; Feinstein
18. 18. Millicurie/mL. Intravenous. Institute
Medical
Research.
NDA 022442.......... REZIRA........... Hydrocodone 5 mg/5 mL; 60 mg/ Solution; Oral.. Persion Pharms.,
Bitartrate; 5 mL. LLC.
Pseudoephedrine
Hydrochloride.
NDA 050757.......... PREVPAC.......... Amoxicillin; 500 mg; 500 mg; Capsule, Tablet, Takeda Pharms.
Clarithromycin; 30 mg. Capsule; Oral. USA, Inc.
Lansoprazole.
NDA 203195.......... SUPRAX........... Cefixime......... 400 mg.......... Capsule; Oral... Lupin, Ltd.
NDA 207931.......... TECHNIVIE........ Ombitasvir; 12.5 mg; 75 mg; Tablet; Oral.... AbbVie Inc.
Paritaprevir; 50 mg.
Ritonavir.
NDA 208624.......... VIEKIRA XR....... Dasabuvir Sodium; EQ 200 mg Base; Tablet, Extended AbbVie Inc.
Ombitasvir; 8.33 mg; 50 mg; Release; Oral.
Paritaprevir; 33.33 mg.
Ritonavir.
----------------------------------------------------------------------------------------------------------------
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 listed are unaffected by the
discontinued marketing of the products subject to those NDAs.
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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06059 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P
