Notice2022-04153
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
Primary source
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Published
February 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 87 Issue 39 (Monday, February 28, 2022)</title>
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[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11079-11080]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04153]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0030]
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five
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 five 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 30, 2022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#317c50434559501f7f564448545f715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="773a1605031f16593910020e121937111316591f1f0459101801">[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 065408............ Epirubicin Fresenius Kabi USA,
Hydrochloride (HCl) LLC, Three Corporate
Injection, 150 Dr., Lake Zurich, IL
milligrams (mg)/75 60047.
milliliters (mL) (2 mg/
mL), 10 mg/5 mL (2 mg/
mL), 50 mg/25 mL (2 mg/
mL), and 200 mg/100 mL
(2 mg/mL).
ANDA 065411............ Epirubicin HCl Do.
Injection, 200 mg/100
mL (2 mg/mL) and 50 mg/
25 mL (2 mg/mL).
ANDA 065440............ Idarubicin HCl Do.
Injection, 1 mg/mL.
ANDA 077790............ Fludarabine Phosphate Hospira, Inc., 275
for Injection, 50 mg/ North Field Dr., Lake
vial. Forest, IL 60045.
ANDA 091008............ Gabapentin Capsules, Jiangsu Hengrui
100 mg, 300 mg, and Pharmaceuticals Co.,
400 mg. Ltd., U.S. Agent,
Venus Pharmaceutical
Laboratories Inc.,
506 Carnegie Center,
Suite 100, Princeton,
NJ 08540.
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[[Page 11080]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
30, 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 March 30, 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: February 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04153 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P
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