Notice2022-16383
Lupin Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
Primary source
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Published
August 1, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 146 (Monday, August 1, 2022)</title>
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[Federal Register Volume 87, Number 146 (Monday, August 1, 2022)]
[Notices]
[Pages 46962-46963]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16383]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1528]
Lupin Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
Seven 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 seven 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of August 31, 2022.
[[Page 46963]]
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#bff2decdcbd7de91f1d8cac6dad1ffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="83cee2f1f7ebe2adcde4f6fae6edc3e5e7e2adebebf0ade4ecf5">[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 065125............ Ceftriaxone for Lupin Pharmaceuticals,
Injection, Equivalent Inc., 111 South
to (EQ) 250 milligrams Calvert St.,
(mg) base/vial; EQ 500 Harborplace Tower,
mg base/vial; EQ 1 21st Floor,
gram (g) base/vial; EQ Baltimore, MD 21202.
2 g base/vial.
ANDA 078188............ Irinotecan Fresenius Kabi USA,
Hydrochloride LLC, Three Corporate
Injection, 40 mg/2 Dr., Lake Zurich, IL
milliliters (mL) (20 60047.
mg/mL) and 100 mg/5 mL
(20 mg/mL).
ANDA 090088............ Anastrozole Tablets, 1 Do.
mg.
ANDA 206002............ Bosentan Tablets, 62.5 Alvogen Pine Brook,
mg and 125 mg. LLC, 44 Whippany Rd.,
Suite 300,
Morristown, NJ 07960.
ANDA 212185............ Chlorzoxazone Tablets, Glenmark
375 mg and 750 mg. Pharmaceuticals Inc.,
USA, 750 Corporate
Dr., Mahwah, NJ
07430.
ANDA 212186............ Amphetamine Sulfate Do.
Tablets, 5 mg and 10
mg.
ANDA 213132............ Arformoterol Tartrate Do.
Inhalation Solution,
EQ 0.015 mg base/2 mL.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 31, 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 August 31, 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: July 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16383 Filed 7-29-22; 8:45 am]
BILLING CODE 4164-01-P
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