[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Pages 38158-38159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09914]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1917]
Fresenius Kabi USA, LLC, et. al.; Withdrawal of Approval of 12
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 12 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of June 6, 2024.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 38159]]
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.
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Application No. Drug Applicant
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ANDA 040379............... Fluorouracil Injectable, Fresenius Kabi
50 milligrams (mg)/ USA, LLC, Three
milliliter (mL). Corporate Dr.,
Lake Zurich, IL
60047.
ANDA 062901............... Ampicillin Sodium; Pfizer Inc., 66
Sulbactam Sodium Hudson Blvd East,
Injectable, Equivalent New York, NY
to (EQ) 2 grams (gm) 10001.
base/vial; EQ 1 gm base/
vial, and EQ 1 gm base/
vial; EQ 500 mg base/
vial.
ANDA 071981............... Droperidol Injectable, Hospira Inc., 275
2.5 mg/mL. North Field Dr.,
Bldg. H1-3S, Lake
Forest, IL 60045.
ANDA 202546............... Ribavirin Tablets, 200 RegCon Solutions,
mg, 400 mg, 500 mg, and LLC, U.S. Agent
600 mg. for Beximco
Pharmaceuticals
USA Inc., 10525
Vista Sorrento
Parkway, Suite
100, San Diego,
CA 92121.
ANDA 203544............... Sodium Fluoride F-18 SOFIE Co. dba
Injectable, 10-200 SOFIE, 21000
millicurie (mCi)/mL. Atlantic Blvd.,
Suite 730,
Dulles, VA 20166.
ANDA 203773............... Dexmedetomidine American Regent,
Hydrochloride (HCl) Inc., 5 Ramsey
Injectable, EQ 200 Rd., Shirley, NY
microgram (mcg) base/2 11967.
mL (EQ 100 mcg base/mL).
ANDA 203884............... Amiodarone HCl Hospira Inc.
Injectable, 50 mg/mL.
ANDA 204315............... Sodium Fluoride F-18 B&H Consulting
Injectable, 10-200 mCi/ Services, Inc.,
mL. U.S. Agent for
Shertech
Laboratories,
LLC, 50 Division
St., Suite 206,
Somerville, NJ
08876.
ANDA 204366............... Ammonia N 13 Injectable, Do.
3.75-260 mCi/mL.
ANDA 204854............... Meropenem for Injection, Freyr Inc., U.S.
500 mg/vial and 1 gm/ Agent for
vial. Daewoong
Pharmaceutical
Co., Ltd., 150
College Rd. West,
Suite 102,
Princeton, NJ
08540.
ANDA 206710............... Paricalcitol Capsules, 1 Alvogen PB
mcg, 2 mcg, and 4 mcg. Research and
Development LLC,
U.S. Agent for
Lotus
Pharmaceutical
Co., Ltd. Nantou
Plant, 44
Whippany Rd.,
Suite 300,
Morristown, NJ
07960.
ANDA 208695............... Bosentan Tablets, 62.5 Hikma
mg, and 125 mg. Pharmaceuticals
USA Inc., 1809
Wilson Rd.,
Columbus, OH
43228.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
6, 2024. 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 listed in the table without an approved new drug application
or ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are
listed in the table that are in inventory on June 6, 2024 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 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09914 Filed 5-6-24; 8:45 am]
BILLING CODE 4164-01-P