Document ID: FDA-2023-N-2079-0001
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Posted Date: 2023-06-02T04:00Z

[Federal Register Volume 88, Number 106 (Friday, June 2, 2023)]
[Notices]
[Pages 36320-36321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11744]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2079]

Hospira, 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 3, 2023.

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.

[[Page 36321]]

------------------------------------------------------------------------
     Application No.               Drug                  Applicant
------------------------------------------------------------------------
ANDA 075160.............  Metoprolol Tartrate     Hospira, Inc., 275
                           Injectable, 1           North Field Dr.,
                           milligram (mg)/         Bldg. H1-3S, Lake
                           milliliter (mL).        Forest, IL 60045.
ANDA 077029.............  Calcipotriene           Tolmar, Inc., 701
                           Solution, 0.005%.       Centre Ave., Fort
                                                   Collins, CO 80526.
ANDA 079186.............  Dorzolamide             American Regent, Inc.,
                           Hydrochloride (HCl)     5 Ramsey Rd.,
                           Solution/Drops,         Shirley, NY 11967.
                           Equivalent to (EQ) 2%
                           base.
ANDA 200457.............  Ibuprofen Suspension,   Arise Pharmaceuticals
                           100 mg/5 mL.            LLC, 12 Roszel Rd.,
                                                   Unit B202, Princeton,
                                                   NJ 08543.
ANDA 204356.............  Ammonia N 13            Wisconsin Medical
                           Injectable, 3.75        Radiopharmacy LLC,
                           millicurie (mCi)-260    11236 West Lapham
                           mCi/mL.                 St., West Allis, WI
                                                   53214.
ANDA 205605.............  Amikacin Sulfate        Fresenius Kabi USA,
                           Injectable, EQ 50 mg    LLC, Three Corporate
                           base/mL.                Dr., Lake Zurich, IL
                                                   60047.
ANDA 205687.............  Ammonia N 13            Essential Isotopes,
                           Injectable, 3.75 mCi-   LLC, 1513 Research
                           260 mCi/mL.             Park Dr., Columbia,
                                                   MO 65211.
ANDA 210265.............  Fludeoxyglucose F18     University of Texas
                           Injectable, 20 mCi/mL-  Southwestern Medical
                           200 mCi/mL.             Center, 5323 Harry
                                                   Hines Blvd., Dallas,
                                                   TX 75390.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
3, 2023. 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 July 3, 2023 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: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11744 Filed 6-1-23; 8:45 am]
BILLING CODE 4164-01-P