[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Page 60902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3248]


Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 
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 23 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 28, 2024.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(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.

             Table 1--ANDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 073462.................  Tolmetin Sodium       Fosun Pharma USA
                               capsule, Equivalent   Inc., 104 Carnegie
                               to (EQ) 400           Center, Suite 204,
                               milligrams (mg)       Princeton, NJ
                               base.                 08540.
ANDA 073588.................  Tolmetin Sodium       Do.
                               tablet, EQ 200 mg
                               base.
ANDA 074002.................  Tolmetin Sodium       Do.
                               tablet, EQ 600 mg
                               base.
ANDA 075631.................  Ketorolac             Baxter Healthcare
                               Tromethamine          Corp., One Baxter
                               injectable, 15 mg/    Parkway, Deerfield,
                               milliliters (mL)      IL 60015.
                               and 30 mg/mL.
ANDA 076427.................  Milrinone Lactate     Do.
                               injectable, EQ 1 mg
                               base/mL.
ANDA 076791.................  Haloperidol Lactate   Do.
                               injectable, EQ 5 mg
                               base/mL.
ANDA 076828.................  Haloperidol Lactate   Do.
                               injectable, EQ 5 mg
                               base/mL.
ANDA 077040.................  Citalopram            Fosun Pharma USA
                               Hydrobromide          Inc.
                               tablet, EQ 10 mg
                               base, EQ 20 mg
                               base, EQ 40 mg base.
ANDA 077947.................  Fluconazole           Baxter Healthcare
                               injectable, 200 mg/   Corp.
                               100 mL (2 mg/mL)
                               and 400 mg/200 mL
                               (2 mg/mL).
ANDA 078197.................  Granisetron           Do.
                               Hydrochloride (HCl)
                               injectable, EQ 0.1
                               mg base/mL (EQ 0.1
                               mg base/mL).
ANDA 079045.................  Bicalutamide tablet,  Fresenius Kabi USA,
                               50 mg.                LLC, Three
                                                     Corporate Dr., Lake
                                                     Zurich, IL 60047.
ANDA 085787.................  Trifluoperazine HCl   Fosun Pharma USA
                               concentrate, EQ 10    Inc.
                               mg base/mL.
ANDA 086808.................  Cyproheptadine HCl    Do.
                               tablet, 4 mg.
ANDA 087774.................  Phenylbutazone        Do.
                               capsule, 100 mg.
ANDA 088602.................  Pseudoephedrine HCl;  Do.
                               Triprolidine HCl
                               tablet, 60 mg;
                               2.5.mg.
ANDA 090367.................  Levofloxacin tablet,  Celltrion USA, Inc.,
                               250 mg, 500 mg, 750   U.S. Agent for
                               mg.                   Celltrion, Inc.,
                                                     One Evertrust
                                                     Plaza, Suite 1207,
                                                     Jersey City, NJ
                                                     07302.
ANDA 091049.................  Ceftriaxone Sodium    EAS Consulting
                               injectable, EQ 250    Group, LLC, U.S.
                               mg base/vial, EQ      Agent for Astral
                               500 mg base/vial,     SteriTech Pvt.
                               EQ 1 gram (g) base/   Ltd., 1700 Diagonal
                               vial, EQ 2 g base/    Rd., Suite 750,
                               vial.                 Alexandria, VA
                                                     22314.
ANDA 091436.................  Levofloxacin          Baxter Healthcare
                               injectable, EQ 500    Corp.
                               mg/20 mL (EQ 25 mg/
                               mL).
ANDA 207032.................  Melphalan HCl         USWM, LLC, 4441
                               injectable, EQ 50     Springdale Rd.,
                               mg base/vial.         Louisville, KY
                                                     40241.
ANDA 207101.................  Sumatriptan           Baxter Healthcare
                               Succinate             Corp.
                               injectable, EQ 6 mg
                               base/0.5 mL (EQ 12
                               mg base/mL).
ANDA 211959.................  Clobazam tablet, 10   Celltrion USA, Inc.,
                               mg and 20 mg.         U.S. Agent for
                                                     Celltrion, Inc.
ANDA 212053.................  Chlorzoxazone         AptaPharma Inc.,
                               tablet, 375 mg and    1533 Union Ave.,
                               750 mg.               Pennsauken, NJ
                                                     08110.
ANDA 215065.................  Methocarbamol         Baxter Healthcare
                               solution, 1 g/10 mL   Corp.
                               (100 mg/mL).
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn as of August 
28, 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 August 28, 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: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16627 Filed 7-26-24; 8:45 am]
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