Notice2022-02053
Watson Laboratories, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Primary source
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Published
February 2, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 87 Issue 22 (Wednesday, February 2, 2022)</title>
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[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5828-5829]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 4, 2022.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.
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Application No. Drug Applicant
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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.
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[[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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