Document ID: FDA-2018-N-1534-0001
Agency: fda
Document Type: Notice
Title: Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications
Posted Date: 2018-05-04T04:00Z

[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Page 19787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09533]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1534]

Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of 
Three 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 three abbreviated new drug applications (ANDAs) 
held by Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical 
Industries, Inc. (Sun Pharmaceutical). These drug products are no 
longer marketed, and Sun Pharmaceutical has requested that the approval 
of the applications be withdrawn.

DATES: Approval is withdrawn as of June 4, 2018.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Sun Pharmaceutical has informed FDA that 
these drug products are no longer marketed and requested that FDA 
withdraw approval of the applications. Sun Pharmaceutical has also 
waived its opportunity for a hearing and requested withdrawal of 
approval under a Consent Decree of Permanent Injunction (Decree) 
entered in United States v. Ranbaxy Laboratories, Ltd. et al., JFM 12-
250 (D. Md.) on January 26, 2012. The Decree specifies that Sun 
Pharmaceutical must never submit another application to FDA for these 
withdrawn drugs and must never transfer these ANDAs to a third party.

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         Application No.                 Drug              Applicant
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ANDA 065174.....................  Clarithromycin      Sun Pharmaceutical
                                   Tablets USP, 250    Industries, Ltd.,
                                   milligrams (mg)     c/o Sun
                                   and 500 mg.         Pharmaceutical
                                                       Industries, Inc.,
                                                       2 Independence
                                                       Way, Princeton,
                                                       NJ 08540.
ANDA 065382.....................  Clarithromycin for  Do.
                                   Oral Suspension
                                   USP, 125 mg/5
                                   milliliters (mL)
                                   and 250 mg/5 mL.
ANDA 075747.....................  Ciprofloxacin       Do.
                                   Tablets USP,
                                   Equivalent to
                                   (EQ) 250 mg base,
                                   EQ 500 mg base,
                                   and EQ 750 mg
                                   base.
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    Therefore, approval of the applications listed in the above table, 
and all amendments and supplements thereto, is hereby withdrawn as of 
June 4, 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)).

    Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09533 Filed 5-3-18; 8:45 am]
 BILLING CODE 4164-01-P