[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11079-11080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 30, 2022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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
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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