[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5828-5829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0074]


Watson Laboratories, 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 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 4, 2022.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#bef3dfcccad6df90f0d9cbc7dbd0fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="b1fcd0c3c5d9d09fffd6c4c8d4dff1d7d5d09fd9d9c29fd6dec7">[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 075152.............  Diclofenac Potassium    Watson Laboratories,
                           Tablets, 50             Inc. (an indirect,
                           milligrams (mg).        wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Bldg. A,
                                                   Parsippany, NJ 07054.
ANDA 091376.............  Topotecan               Fresenius Kabi USA,
                           Hydrochloride (HCl)     LLC, Three Corporate
                           for Injection,          Dr., Lake Zurich, IL
                           Equivalent to (EQ) 4    60047.
                           mg base/vial.
ANDA 091471.............  Efavirenz Tablets, 600  Mylan Pharmaceuticals
                           mg.                     Inc., a Viatris
                                                   Company, 3711 Collins
                                                   Ferry Rd.,
                                                   Morgantown, WV 26505.
ANDA 200463.............  Itraconazole Capsules,  Mylan Pharmaceuticals
                           100 mg.                 Inc., a Viatris
                                                   Company, 781 Chestnut
                                                   Ridge Rd.,
                                                   Morgantown, WV 26504.
ANDA 202395.............  Ziprasidone HCl         Do.
                           Capsules, EQ 20 mg
                           base, EQ 40 mg base,
                           EQ 60 mg base, and EQ
                           80 mg base.
ANDA 203170.............  Docetaxel Injection,    Jiangsu Hengrui
                           40 mg/milliliter.       Pharmaceuticals Co.,
                                                   Ltd., U.S. Agent,
                                                   eVenus Pharmaceutical
                                                   Laboratories Inc.,
                                                   506 Carnegie Center,
                                                   Suite 100, Princeton,
                                                   NJ 08540.
ANDA 203574.............  Mesalamine Delayed      Mylan Pharmaceuticals
                           Release Tablets, 1.2    Inc., a Viatris
                           grams.                  Company, 781 Chestnut
                                                   Ridge Rd.,
                                                   Morgantown, WV 26504.
ANDA 208177.............  Atazanavir Sulfate      Do.
                           Capsules, EQ 150 mg
                           base, EQ 200 mg base,
                           and EQ 300 mg base.
------------------------------------------------------------------------


[[Page 5829]]

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of March 
4, 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 4, 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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02053 Filed 2-1-22; 8:45 am]
BILLING CODE 4164-01-P


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