2020-15727. Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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    Approval is withdrawn as of August 20, 2020.

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    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, 240-402-6980, Martha.Nguyen@fda.hhs.gov.

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    SUPPLEMENTARY INFORMATION:

    The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described 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.

    Application No.DrugApplicant
    ANDA 060709Oleandomycin InjectionRoerig Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
    ANDA 061087Benzocaine, Oxytetracycline Hydrochloride (HCl), and Polymyxin B Sulfate Otic SolutionPfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
    ANDA 061725Tetracycline HCl Capsules, 250 milligrams (mg) and 500 mgWarner Chilcott Division of Warner Lambert-Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
    ANDA 061943Chloramphenicol Ophthalmic Solution, 0.5%Lederle Laboratories, Division of American Cyanamid Co., 1 Cyanamid Plaza, Wayne, NJ 07470.
    ANDA 062175Tetracycline HCl Capsules, 250 mgWarner Chilcott Division of Warner Lambert-Pfizer, Inc.
    ANDA 062215Oxytetracycline HCl CapsulesLederle Laboratories, Division of American Cyanamid Co.
    ANDA 076203Ribavirin Capsules, 200 mgKadmon Pharmaceuticals, LLC, 119 Commonwealth Dr., Warrendale, PA 15086.
    ANDA 077456Ribavirin Tablets, 200 mg, 400 mg, and 600 mgDo.
    ANDA 084669Chlorpropamide Tablets, 250 mgSandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
    ANDA 201750Articaine HCI and Epinephrine Bitartrate for Injection, 4%; Equivalent to (EQ) 0.017 mg base/1.7 milliliters (mL); (4%; EQ 0.01 mg base/mL)Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323.

    Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 20, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on August 20, 2020 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.

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    Dated: July 15, 2020.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

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    [FR Doc. 2020-15727 Filed 7-20-20; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
07/21/2020
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2020-15727
Dates:
Approval is withdrawn as of August 20, 2020.
Pages:
44096-44096 (1 pages)
Docket Numbers:
Docket No. FDA-2020-N-1227
PDF File:
2020-15727.Pdf
Supporting Documents:
» Roerig Division of Pfizer Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications; Correction
» Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications