Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications, 70852 [2021-26892]
Download as PDF
<![CDATA[
70852
Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
guidance finalizes the guidance issued
on May 27, 2020.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Q3C(R8)
Impurities: Guidance for Residual
Solvents.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 58 have been
approved under OMB control number
0910–0119.
Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26889 Filed 12–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1287]
Actavis LLC, et al.; Withdrawal of
Approval of Six Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
khammond on DSKJM1Z7X2PROD with NOTICES
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
Application No.
Drug
ANDA 202603 ...........
Methoxsalen Capsules, 10 milligrams (mg) ...........
ANDA 205274 ...........
Amoxicillin Tablets, 125 mg and 250 mg ...............
ANDA 205513 ...........
Carisoprodol Tablets, 250 mg and 350 mg ............
ANDA 206410 ...........
ANDA 207536 ...........
ANDA 208227 ...........
Itraconazole Capsules, 100 mg ..............................
Flucytosine Capsules, 250 mg and 500 mg ...........
Dutasteride Capsules, 0.5 mg ................................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 12,
2022. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on January 12,
2022, may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
VerDate Sep<11>2014
16:50 Dec 10, 2021
Jkt 256001
Approval is withdrawn as of
January 12, 2022.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Applicant
Actavis LLC, (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.
Hikma Pharmaceuticals LLC, 1809 Wilson Rd., Columbus, OH
43228.
Strides Pharma Global Pte. Limited, U.S. Agent, Strides Pharma
Inc., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ
08816.
Do.
Do.
Do.
expiration dates or otherwise become
violative, whichever occurs first.
Dated: December 7, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26892 Filed 12–10–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Single-Source Supplement for Title X
Services in Texas
Office of Population Affairs,
Office of the Assistant Secretary for
Health, Office of the Secretary,
Department of Health and Human
Services (HHS).
AGENCY:
PO 00000
withdrawing approval of six abbreviated
new drug applications (ANDAs) 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.
Frm 00039
Fmt 4703
Sfmt 4703
ACTION:
Notice.
The Office of Population
Affairs (OPA) announces the award of a
single-source supplement to provide
Title X family planning services in
Texas to Women’s Health and Family
Planning Association of Texas (d.b.a.
Every Body Texas). The supplement
will enable Every Body Texas to expand
provision of emergency contraception
and other family planning services to
clients across the state of Texas to
address the anticipated increased
demand for family planning services
following passage of TX SB8.
DATES: December 13, 2021.
FOR FURTHER INFORMATION CONTACT:
Jessica Swafford Marcella, Deputy
Assistant Secretary for Population
SUMMARY:
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Page 70852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26892]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1287]
Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of six abbreviated new drug applications (ANDAs)
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 January 12, 2022.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 202603.................. Methoxsalen Actavis LLC, (an
Capsules, 10 indirect, wholly
milligrams (mg). owned subsidiary of
Teva Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Bldg. A, Parsippany,
NJ 07054.
ANDA 205274.................. Amoxicillin Hikma Pharmaceuticals
Tablets, 125 mg LLC, 1809 Wilson Rd.,
and 250 mg. Columbus, OH 43228.
ANDA 205513.................. Carisoprodol Strides Pharma Global
Tablets, 250 mg Pte. Limited, U.S.
and 350 mg. Agent, Strides Pharma
Inc., 2 Tower Center
Blvd., Suite 1102,
East Brunswick, NJ
08816.
ANDA 206410.................. Itraconazole Do.
Capsules, 100 mg.
ANDA 207536.................. Flucytosine Do.
Capsules, 250 mg
and 500 mg.
ANDA 208227.................. Dutasteride Do.
Capsules, 0.5 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 12, 2022. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on January 12, 2022, 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: December 7, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26892 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P
