Document ID: FDA-2022-N-1528-0001
Agency: fda
Document Type: Notice
Title: Lupin Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
Posted Date: 2022-08-01T04:00Z

[Federal Register Volume 87, Number 146 (Monday, August 1, 2022)]
[Notices]
[Pages 46962-46963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 31, 2022.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, [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 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.
------------------------------------------------------------------------

    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