Notice2023-23064
American Regent, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 88 Issue 201 (Thursday, October 19, 2023)</title>
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[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72082-72083]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4414]
American Regent, Inc., et al.; Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of eight 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of November 20, 2023.
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#d39eb2a1a7bbb2fd9db4a6aab6bd93b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="d994b8abadb1b8f797beaca0bcb799bfbdb8f7b1b1aaf7beb6af">[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 the 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 040515..................... Promethazine American Regent,
Hydrochloride Inc., 5 Ramsey
Injectable, 25 Rd., Shirley, NY
milligrams (mg)/ 11967.
milliliter (mL).
ANDA 080028..................... Sulfacetamide Allergan Sales,
Sodium Solution/ LLC, 2525 Dupont
Drops, 10% and Dr., Irvine, CA
30%. 92612.
ANDA 091300..................... Riluzole Tablet, Apotex Corp., U.S.
50 mg. Agent for Apotex
Inc., 2400 North
Commerce Parkway,
Suite 400,
Weston, FL 33326.
ANDA 200271..................... Hydroxyprogesteron Lachman Consultant
e Caproate Services, Inc.,
Solution, 1,250 U.S. Agent for
mg/5 mL (250 mg/ Aspen Global
mL). Inc., 1600
Stewart Ave.,
Suite 604,
Westbury, NY
11590.
ANDA 201570..................... Abacavir Sulfate Apotex Corp., U.S.
Tablet, Agent for Apotex
Equivalent to Inc.
(EQ) 300 mg base.
[[Page 72083]]
ANDA 202784..................... Esomeprazole Hetero USA, Inc.,
Magnesium U.S. Agent for
Capsule, Delayed Hetero Labs Ltd.,
Release Pellets, Unit-III, 1035
EQ 20 mg base and Centennial Ave.,
EQ 40 mg base. Piscataway, NJ
08854.
ANDA 208413..................... Choline C-11 Washington
Injectable, 4- University School
33.1 millicurie/ of Medicine, 510
mL. South
Kingshighway
Blvd., St. Louis,
MO 63110.
ANDA 208939..................... Esomeprazole Hetero USA, Inc.,
Magnesium U.S. Agent for
Capsule, Delayed Hetero Labs Ltd.
Release, EQ 20 mg
base.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 20, 2023. 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 listed in the table without an approved new drug
application or abbreviated new drug application violates sections
505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(a) and 331(d)). Drug products that are listed in the table
that are in inventory on November 20, 2023 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: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23064 Filed 10-18-23; 8:45 am]
BILLING CODE 4164-01-P
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