Document ID: FDA-2023-N-0722-0001
Agency: fda
Document Type: Notice
Title: Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Posted Date: 2023-03-16T04:00Z

[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16271-16272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 17, 2023.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, [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 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.
------------------------------------------------------------------------

    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