2018-05120. Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications  

  • Start Preamble Start Printed Page 11208

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is withdrawing approval of four abbreviated new drug applications (ANDAs) from two applicants. The holders of the applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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    Approval is withdrawn as of April 13, 2018.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    The holders of the applications 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 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 075556Enalapril Maleate Tablets USP, 2.5 milligrams (mg), 5 mg, 10 mg, and 20 mgSun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
    ANDA 076045Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mgDo.
    ANDA 078055Zolpidem Tartrate Tablets USP, 5 mg and 10 mgDo.
    ANDA 090018Zoledronic Acid for Injection, Equivalent to 4 mg base/vialSun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.

    Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 13, 2018. 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 April 13, 2018 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.

    Start Signature

    Dated: March 8, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2018-05120 Filed 3-13-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
03/14/2018
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2018-05120
Dates:
Approval is withdrawn as of April 13, 2018.
Pages:
11208-11208 (1 pages)
Docket Numbers:
Docket No. FDA-2018-N-0793
PDF File:
2018-05120.Pdf