Notice2021-26892
Actavis LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Primary source
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Published
December 13, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 86 Issue 236 (Monday, December 13, 2021)</title>
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[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Page 70852]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26892]
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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.
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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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of January 12, 2022.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, <a href="/cdn-cgi/l/email-protection#7e331f0c0a161f5030190b071b103e181a1f5016160d50191108"><span class="__cf_email__" data-cfemail="efa28e9d9b878ec1a1889a968a81af898b8ec187879cc1888099">[email protected]</span></a>.
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.
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Application No. Drug Applicant
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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.
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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
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