Document ID: FDA-2016-N-4320-0001
Agency: fda
Document Type: Notice
Title: Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28
Abbreviated New Drug Applications
Posted Date: 2016-12-20T05:00Z

[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92821-92822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30623]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4320]

Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 28 abbreviated new drug applications held by Sun Pharmaceutical 
Industries, Inc. (Sun Pharmaceutical), U.S. Agent for Sun 
Pharmaceutical Industries Limited, 270 Prospect Plains Rd., Cranbury, 
NJ 08512. The drug products are no longer marketed, and Sun 
Pharmaceutical has requested that the approval of the applications be 
withdrawn.

DATES: January 19, 2017.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The applications listed in the table in this 
document are no longer marketed, and Sun Pharmaceutical has requested 
that FDA withdraw approval of the applications. The company has also, 
by its request, waived its opportunity for a hearing.

------------------------------------------------------------------------
         Application No.                            Drug
------------------------------------------------------------------------
065007...........................  Cephalexin Capsules USP, Equivalent
                                    to (EQ) 250 milligrams (mg) base and
                                    EQ 500 mg base.
065016...........................  Amoxicillin Capsules USP, 250 mg and
                                    500 mg.
065021...........................  Amoxicillin Tablets USP (Chewable),
                                    125 mg and 250 mg.
065059...........................  Amoxicillin Tablets USP, 500 mg and
                                    875 mg.
065060...........................  Amoxicillin Tablets USP (Chewable),
                                    200 mg and 400 mg.
065081...........................  Cephalexin for Oral Suspension USP,
                                    EQ 125 mg base/5 milliliters (mL)
                                    and EQ 250 mg base/5 mL.
065082...........................  Cefpodoxime Proxetil for Oral
                                    Suspension USP, EQ 50 mg base/5 mL
                                    and EQ 100 mg base/5 mL.
065083...........................  Cefpodoxime Proxetil Tablets USP, EQ
                                    100 mg base and EQ 200 mg base.

[[Page 92822]]

 
065102...........................  Amoxicillin and Clavulanate Potassium
                                    Tablets USP, 875 mg/EQ 125 mg base.
065109...........................  Amoxicillin and Clavulanate Potassium
                                    Tablets USP, 500 mg/EQ 125 mg base.
065113...........................  Amoxicillin for Oral Suspension USP,
                                    200 mg/5 mL and 400 mg/5 mL.
065115...........................  Cefadroxil for Oral Suspension USP,
                                    EQ 125 mg base/5 mL, EQ 250 mg base/
                                    5 mL, and EQ 500 mg base/5 mL.
065118...........................  Cefuroxime Axetil Tablets USP, EQ 125
                                    mg base, EQ 250 mg base, and EQ 500
                                    mg base.
065132...........................  Amoxicillin and Clavulanate Potassium
                                    for Oral Suspension USP, 200 mg/EQ
                                    28.5 mg base per 5 mL and 400 mg/EQ
                                    57 mg base per 5 mL.
065161...........................  Amoxicillin and Clavulanate Potassium
                                    Tablets USP (Chewable), 200 mg/EQ
                                    28.5 mg base and 400 mg/EQ 57 mg
                                    base.
065207...........................  Amoxicillin and Clavulanate Potassium
                                    for Oral Suspension USP, 600 mg/EQ
                                    42.9 mg base per 5 mL.
065323...........................  Cefuroxime Axetil for Oral Suspension
                                    USP, EQ 125 mg base/5 mL and EQ 250
                                    mg base/5 mL.
074975...........................  Acyclovir Capsules USP, 200 mg.
074980...........................  Acyclovir Tablets USP, 400 mg and 800
                                    mg.
075132...........................  Ranitidine Tablets USP, EQ 75 mg
                                    base.
075439...........................  Ranitidine Tablets USP, EQ 150 mg
                                    base and EQ 300 mg base.
076041...........................  Sotret (isotretinoin) Capsules USP,
                                    10 mg, 20 mg, and 40 mg.
076285...........................  Simvastatin Tablets USP, 5 mg, 10 mg,
                                    20 mg, 40 mg, and 80 mg.
076332...........................  Fluconazole for Oral Suspension, 10
                                    mg/mL and 40 mg/mL.
076409...........................  Nefazodone Hydrochloride Tablets USP,
                                    50 mg, 100 mg, 150 mg, 200 mg, and
                                    250 mg.
076503...........................  Sotret (isotretinoin) Capsules USP,
                                    30 mg.
076606...........................  Gabapentin Capsules USP, 100 mg, 300
                                    mg, and 400 mg.
076739...........................  Fosinopril Sodium and
                                    Hydrochlorothiazide Tablets USP, 10
                                    mg/12.5 mg and 20 mg/12.5 mg.
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research, by the Commissioner, 
approval of the applications listed in the table, and all amendments 
and supplements thereto, is hereby withdrawn, effective January 19, 
2017.

    Dated: December 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30623 Filed 12-19-16; 8:45 am]
 BILLING CODE 4164-01-P