[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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 3, 2023.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]]
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Application No. Drug Applicant
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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.
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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