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Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

89 Fed. Reg. 76849 (Sep. 19, 2024)

Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

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Federal RegisterSep 19, 2024
89 Fed. Reg. 76849 (Sep. 19, 2024)
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    Department of Health and Human Services Food and Drug Administration
  • [Docket No. FDA-2024-N-4289]

    • AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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    Approval is withdrawn as of October 21, 2024.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, Martha.Nguyen@fda.hhs.gov.

    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 § 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 § 314.150(c) is without prejudice to refiling.

    Table 1—ANDAs for Which Approval Is Withdrawn

    Application No. Drug Applicant
    ANDA 062452 Gentamicin Sulfate solution/drop, Equivalent to (EQ) 0.3% base Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92612.
    ANDA 064124 Cefuroxime Sodium injectable, EQ 7.5 grams (g) base/vial ACS Dobfar S.p.A., U.S. Agent Interchem Corp., 120 Route 17 North, Paramus, NJ 07652.
    ANDA 077151 Milrinone Lactate injectable, EQ 40 milligrams (mg) base/200 milliliters (mL) (EQ 0.2 mg base/mL) EQ 20 mg base/100 mL (EQ 0.2 mg base/mL) Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite A, Wixom, MI 48393.
    ANDA 079032 Ondansetron Hydrochloride preservative free injectable, EQ 2 mg base/mL American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
    ANDA 079075 Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base Watson Laboratories, Inc., (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.
    ANDA 206155 Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg Indoco Remedies Ltd., U.S. Agent RegCon Solutions, LLC, 9920 Pacific Heights Blvd., Suite 250, San Diego, CA 92121.
    ANDA 206204 Piperacillin Sodium and Tazobactam Sodium injectable, EQ 12 gm base/vial, EQ 1.5 gm base/vial Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
    ANDA 207919 Acyclovir Sodium injectable, EQ 50 mg base/mL Dr. Reddy's Laboratories, Inc., 107 College Rd. East, Princeton, NJ 08540.
    ANDA 209708 Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/mL) Woodward Pharma Services, LLC.