Document ID: FDA-2018-N-1336-0001
Agency: fda
Document Type: Notice
Title: Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications
Posted Date: 2018-04-11T04:00Z

[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15577-15578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07440]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1336]

Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 
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 18 abbreviated new drug applications (ANDAs) 
from multiple 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of May 11, 2018.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: 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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

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     Application No.                Drug                 Applicant
------------------------------------------------------------------------
ANDA 040252..............  Carisoprodol and        Oxford
                            Aspirin Tablets USP,    Pharmaceuticals,
                            200 milligrams (mg)/    LLC, 301 Leaf Lake
                            325 mg.                 Pkwy., Birmingham,
                                                    AL 35211.
ANDA 040283..............  Carisoprodol, Aspirin,  Do.
                            and Codeine Phosphate
                            Tablets USP, 200 mg/
                            325 mg/16 mg.
ANDA 061214..............  Tetracycline            Roxane Laboratories,
                            Hydrochloride (HCl)     Inc., 1809 Wilson
                            Capsules USP, 250 mg    Rd., Columbus, OH
                            and 500 mg.             43228.
ANDA 061682..............  Tetracycline HCl        Mylan Pharmaceuticals
                            Tablets, 500 mg.        Inc., P.O. Box 4293,
                                                    Morgantown, WV
                                                    26505.
ANDA 062212..............  Totacillin (ampicillin/ GlaxoSmithKline, Five
                            ampicillin              Moore Dr., P.O. Box
                            trihydrate) Capsules,   13398, Research
                            Equivalent to (EQ)      Triangle Park, NC
                            250 mg base and EQ      27709.
                            500 mg base.
ANDA 062654..............  Rocephin (ceftriaxone   Hoffman La-Roche,
                            sodium) for             Inc., c/o Genentech,
                            Injection, EQ 500 mg    Inc., 1 DNA Way, MS
                            base/vial, EQ 1 gram    241B, South San
                            (g) base/vial, and EQ   Francisco, CA 94080.
                            2 g base/vial.
ANDA 062680..............  Oxacillin Sodium for    ACS Dobfar S.p.A., c/
                            Injection (Pharmacy     o Interchem Corp.,
                            Bulk Package).          120 Route 17 North,
                                                    Paramus, NJ 07653.
ANDA 065124..............  Cefotaxime for          Lupin Ltd., c/o Lupin
                            Injection USP, EQ 500   Pharmaceuticals,
                            mg base/vial, EQ 1 g    Inc., 111 South
                            base/vial, and EQ 2 g   Calvert St.,
                            base/vial.              Harborplace Tower,
                                                    24th Floor,
                                                    Baltimore, MD 21202.
ANDA 065263..............  Ceftriaxone for         Do.
                            Injection USP, EQ 10
                            g base/vial (Pharmacy
                            Bulk Package).
ANDA 074845..............  Diltiazem HCl Extended- Biovail Corp.
                            Release Capsules USP,   International,
                            60 mg, 90 mg, and 120   Subsidiary of
                            mg.                     Valeant
                                                    Pharmaceuticals
                                                    North America, LLC,
                                                    400 Somerset
                                                    Corporate Blvd.,
                                                    Bridgewater, NJ
                                                    08807.

[[Page 15578]]

 
ANDA 077173..............  Ondansetron Injection   Sun Pharmaceutical
                            USP, EQ 2 mg base/      Industries Ltd., c/o
                            milliliter (mL).        Sun Pharmaceutical
                                                    Industries, Inc., 2
                                                    Independence Way,
                                                    Princeton, NJ 08540.
ANDA 078598..............  Ciprofloxacin           Amring
                            Ophthalmic Solution     Pharmaceuticals,
                            USP, EQ 0.3% base.      Inc., 1235 Westlakes
                                                    Dr., Suite 205,
                                                    Berwyn, PA 19312.
ANDA 078805..............  Irinotecan HCl          Sun Pharma Global
                            Injection, 20 mg/mL.    FZE, c/o Sun
                                                    Pharmaceutical
                                                    Industries, Inc., 2
                                                    Independence Way,
                                                    Princeton, NJ 08540.
ANDA 086024..............  Capital and Codeine     Valeant
                            (acetaminophen and      Pharmaceuticals
                            codeine phosphate)      North America, LLC,
                            Oral Suspension USP,    400 Somerset
                            120 mg/12 mg per 5 mL.  Corporate Blvd.,
                                                    Bridgewater, NJ
                                                    08807.
ANDA 091180..............  Dorzolamide HCl and     Zambon S.p.A., c/o
                            Timolol Maleate         Camargo
                            Ophthalmic Solution,    Pharmaceutical
                            EQ 2% base/EQ 0.5%      Services, LLC, 9825
                            base.                   Kenwood Rd., Suite
                                                    203, Cincinnati, OH
                                                    45242.
ANDA 203176..............  Nevirapine Tablets      Technology Organized,
                            USP, 200 mg.            LLC, 9191 Point
                                                    Replete Dr., Fort
                                                    Belvoir, VA 22060.
ANDA 204900..............  Amlodipine Besylate     Sovereign
                            Tablets USP, EQ 2.5     Pharmaceuticals,
                            mg base, EQ 5 mg        LLC, 7590 Sand St.,
                            base, and EQ 10 mg      Fort Worth, TX
                            base.                   76118.
ANDA 209480..............  Clozapine Tablets USP,  Zydus Pharmaceuticals
                            25 mg, 50 mg, 100 mg,   USA, Inc., 73 Route
                            and 200 mg.             31 North,
                                                    Pennington, NJ
                                                    08534.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of May 
11, 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 May 11, 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.

    Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07440 Filed 4-10-18; 8:45 am]
 BILLING CODE 4164-01-P