Notice2023-05360
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Primary source
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Published
March 16, 2023
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 88 Issue 51 (Thursday, March 16, 2023)</title>
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16271-16272]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05360]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0722]
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
[[Page 16272]]
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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of April 17, 2023.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#4904283b3d212867072e3c302c27092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="a4e9c5d6d0ccc58aeac3d1ddc1cae4c2c0c58accccd78ac3cbd2">[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 065111................... Kanamycin Sulfate Fresenius Kabi USA,
Injection, LLC, Three Corporate
Equivalent to Dr., Lake Zurich, IL
(EQ) 500 60047.
milligrams (mg)
base/2
milliliters (mL)
and EQ 1 gram
(g) base/3 mL.
ANDA 079107................... Levetiracetam Tolmar, Inc., 701
Solution, 100 mg/ Centre Ave., Fort
mL. Collins, CO 80526.
ANDA 201832................... Nimodipine Sofgen
Capsules, 30 mg. Pharmaceuticals,
LCC, 21500 Biscayne
Blvd., Suite 600,
Aventura, FL 33180.
ANDA 202418................... Lamivudine and Aurobindo Pharma USA,
Zidovudine Inc., U.S. Agent for
Tablets, 150 mg; Aurobindo Pharma
300 mg. Ltd., 279 Princeton-
Hightstown Rd., East
Windsor, NJ 08520.
ANDA 202743................... Azelastine Padagis US LLC., U.S.
Hydrochloride Agent for Padagis
(HCl), Metered Israel
Spray, 0.2055 mg/ Pharmaceuticals Ltd.
spray. (formerly known as
Perrigo Israel
Pharmaceuticals
Ltd.), 3940 Quebec
Avenue North,
Minneapolis, MN
55427.
ANDA 203937................... Fludeoxyglucose Hot Shots NM, LLC,
F18 Injection, 4- DBA Midwest Positron
500 millicurie Technology, LC, 2017
(mCi)/mL. E Kimberly Rd.,
Suite C, Davenport
IA 52807.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
17, 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 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 April 17, 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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05360 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
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