[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Page 76849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4289]


Allergan, Inc., et al.; Withdrawal of Approval of Nine 
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 nine 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of October 21, 2024.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                                 Table 1--ANDAs for Which Approval Is Withdrawn
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       Application No.                          Drug                                    Applicant
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ANDA 062452.................  Gentamicin Sulfate solution/drop,         Allergan, Inc., 2525 Dupont Dr., P.O.
                               Equivalent to (EQ) 0.3% base.             Box 19534, Irvine, CA 92612.
ANDA 064124.................  Cefuroxime Sodium injectable, EQ 7.5      ACS Dobfar S.p.A., U.S. Agent Interchem
                               grams (g) base/vial.                      Corp., 120 Route 17 North, Paramus, NJ
                                                                         07652.
ANDA 077151.................  Milrinone Lactate injectable, EQ 40       Woodward Pharma Services, LLC, 47220
                               milligrams (mg) base/200 milliliters      Cartier Dr., Suite A, Wixom, MI 48393.
                               (mL) (EQ 0.2 mg base/mL) EQ 20 mg base/
                               100 mL (EQ 0.2 mg base/mL).
ANDA 079032.................  Ondansetron Hydrochloride preservative    American Regent, Inc., 5 Ramsey Rd.,
                               free injectable, EQ 2 mg base/mL.         Shirley, NY 11967.
ANDA 079075.................  Fentanyl Citrate tablet, EQ 0.1 mg base,  Watson Laboratories, Inc., (an indirect,
                               EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6    wholly owned subsidiary of Teva
                               mg base, and EQ 0.8 mg base.              Pharmaceuticals USA, Inc.), 400
                                                                         Interpace Pkwy., Bldg. A, Parsippany,
                                                                         NJ 07054.
ANDA 206155.................  Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg,  Indoco Remedies Ltd., U.S. Agent RegCon
                               10 mg, 15 mg, and 20 mg.                  Solutions, LLC, 9920 Pacific Heights
                                                                         Blvd., Suite 250, San Diego, CA 92121.
ANDA 206204.................  Piperacillin Sodium and Tazobactam        Fresenius Kabi USA, LLC, Three Corporate
                               Sodium injectable, EQ 12 gm base/vial,    Dr., Lake Zurich, IL 60047.
                               EQ 1.5 gm base/vial.
ANDA 207919.................  Acyclovir Sodium injectable, EQ 50 mg     Dr. Reddy's Laboratories, Inc., 107
                               base/mL.                                  College Rd. East, Princeton, NJ 08540.
ANDA 209708.................  Mivacurium Chloride solution, EQ 10 mg    Woodward Pharma Services, LLC.
                               base/5 mL (EQ 2 mg base/mL) and EQ 20
                               mg base/10 mL (EQ 2 mg base/mL).
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    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn as of October 
21, 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 October 21, 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: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21432 Filed 9-18-24; 8:45 am]
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