Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications, 19787 [2018-09533]

Download as PDF Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices Dated: April 23, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. incorrect docket number. This document corrects that error. Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, April 9, 2018 (83 FR 15152), in FR Doc. 2018– 07147, on page 15152, the following correction is made: 1. On page 15152, in the second column, in the first line of the list of docket numbers, ‘‘FDA–2014–N–0075’’ is corrected to read ‘‘FDA–2011–N– 0075.’’ BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–N–0075; FDA– 2011–N–0015; FDA–2011–N–0076; FDA– 2017–N–0932; FDA–2016–N–4487; FDA– 2014–N–0345; FDA–2013–N–0523; FDA– 2017–N–2428; FDA–2008–N–0312; and FDA–2014–N–1072] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals; Correction AGENCY: Food and Drug Administration, Dated: April 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–09437 Filed 5–3–18; 8:45 am] BILLING CODE 4164–01–P HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals’’ that appeared in the Federal Register of April 9, 2018. The document announced a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. The document was published with an SUMMARY: 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: 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drug products are no longer marketed, and Sun Pharmaceutical has requested that the approval of the applications be withdrawn. SUMMARY: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2018–09532 Filed 5–3–18; 8:45 am] 19787 Notice. Approval is withdrawn as of June 4, 2018. DATES: 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. 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. SUPPLEMENTARY INFORMATION: Application No. Drug Applicant ANDA 065174 ......... Clarithromycin Tablets USP, 250 milligrams (mg) and 500 mg. ANDA 065382 ......... Clarithromycin for Oral Suspension USP, 125 mg/5 milliliters (mL) and 250 mg/5 mL. Ciprofloxacin Tablets USP, Equivalent to (EQ) 250 mg base, EQ 500 mg base, and EQ 750 mg base. Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. Do. ANDA 075747 ......... Do. amozie on DSK3GDR082PROD with NOTICES 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)). DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 1, 2018. Leslie Kux, Associate Commissioner for Policy. HHS. [FR Doc. 2018–09533 Filed 5–3–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:16 May 03, 2018 Jkt 244001 Food and Drug Administration [Docket No. FDA–2018–N–1564] Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications AGENCY: ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The SUMMARY: PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 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 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, Trang.Tran@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[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.

-----------------------------------------------------------------------

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.

------------------------------------------------------------------------
         Application No.                 Drug              Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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


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