[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52057-52058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13660]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2803]
Sandoz Inc., et al.; Withdrawal of Approval of 20 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 20 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 22, 2024.
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, 301-
796-3471, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(copyright) (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 52058]]
Table--ANDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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ANDA 040118................. Carisoprodol, Sandoz Inc., 100
Aspirin and Codeine College Rd. West,
Phosphate Tablets, Princeton, NJ
325 milligrams 08540.
(mg), 200 mg, and
16 mg.
ANDA 040291................. Fluorouracil Fresenius Kabi USA,
Injection, 50 mg/ LLC, Three
milliliters (mL). Corporate Dr., Lake
Zurich, IL 60047.
ANDA 071849................. Morphine Sulfate Hospira, Inc., 275
Injectable, 0.5 mg/ North Field Dr.,
mL. Building H1-3S,
Lake Forest, IL
60045.
ANDA 074133................. Metoprolol Tartrate Do.
Injectable, 1 mg/mL.
ANDA 076648................. Nitrofurantoin Aurobindo Pharma USA
(Monohydrate/ Inc., 279 Princeton-
Macrocrystals) Hightstown Rd.,
Capsules, 75 mg, East Windsor, NJ
and 25 mg. 08520.
ANDA 077387................. Ondansetron American Regent,
Hydrochloride (HCl) Inc., 5 Ramsey Rd.,
Preservative Free Shirley, NY 11967.
Injection,
Equivalent to (EQ)
2 mg base/mL.
ANDA 077582................. Ondansetron HCl Do.
Injectable, EQ 2 mg
base/mL.
ANDA 079039................. Ondansetron HCl Do.
Injection, EQ 2 mg
base/mL.
ANDA 087440................. Dexamethasone Sodium Do.
Phosphate
Injection, EQ 4 mg
phosphate/mL.
ANDA 088388................. Mepivacaine HCl and ICON Clinical
Levonordefrin Research, LLC, U.S.
Injection, 0.05 mg/ Agent for Deproco,
mL; 2%. Inc., 4130 ParkLake
Ave., Suite 400,
Raleigh, NC 27612.
ANDA 090578................. Ampicillin and EAS Consulting
Sulbactam For Group, LLC, U.S.
Injection, EQ 10 Agent for Astral
grams(g) base/vial SteriTech Pvt.
and EQ 5 grams (g) Ltd., 1700 Diagonal
base/vial. Rd., #750,
Alexandria, VA
22314.
ANDA 090579................. Ampicillin and Do.
Sulbactam For
Injection, EQ 1 g
base/vial, EQ 500
mg base/vial, EQ 2
g base/vial, and EQ
1 g base/vial.
ANDA 090723................. Duloxetine HCl Marksans Pharma,
Capsules, Delayed- Inc., U.S. Agent
Release Pellets, EQ for Marksans Pharma
20 mg base, EQ 30 Ltd., 150 Motor
mg base, and EQ 60 Pkwy., Suite 401,
mg base. 4th Floor, Rm. 430,
Hauppauge, NY
11788.
ANDA 207266................. Bupivacaine HCl Baxter Healthcare
Injectable, 0.75%. Corp., One Baxter
Pkwy., Deerfield,
IL 60015.
ANDA 207794................. Busulfan Injection, Nexus
6 mg/mL. Pharmaceuticals,
Inc., 400
Knightsbridge
Pkwy.,
Lincolnshire, IL
60069.
ANDA 209068................. Chlorthalidone Elity LLC, U.S.
Tablets, 25 mg and Agent for Sunny
50 mg. Pharmtech Inc., 175
SW 166th Ave.,
Pembroke Pines, FL
33027.
ANDA 212223................. Captopril Tablets, Pharmobedient
12.5 mg, 25 mg, 50 Consulting, LLC,
mg, and 100 mg. U.S. Agent for
Seton
Pharmaceuticals,
LLC, 642 North East
3rd Ave., Fort
Lauderdale, FL
33304.
ANDA 212287................. Piperacillin and EAS Consulting
Tazobactam For Group, LLC.
Injection, EQ 2 g
base/vial, EQ 250
mg base/vial, EQ 3
g base/vial, EQ 375
mg base/vial, EQ 4
g base/vial, and EQ
500 mg base/vial.
ANDA 212721................. Cefepime HCl For Do.
Injection, EQ 1 g
base/vial and EQ 2
g base/vial.
ANDA 213552................. Succinylcholine Nexus
Chloride Injection, Pharmaceuticals,
20 mg/mL. Inc.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of July 22,
2024. Approval of each entire application is withdrawn, including any
strengths and dosage forms inadvertently missing from table 1.
Introduction or delivery for introduction into interstate commerce of
products listed in table 1 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 table 1 that are in inventory on July 22, 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: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13660 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P