[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 22, 2024.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              Table--ANDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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