[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35654-35655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2493]


ICU Medical, Inc., et al.; Withdrawal of Approval of 31 
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 31 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 27, 2018.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, 
<a href="/cdn-cgi/l/email-protection#96c2e4f7f8f1b8c2e4f7f8d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="7e2a0c1f1019502a0c1f103e181a1f5016160d50191108">[email protected]</span></a>.

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 described 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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
ANDA 020345............  Aminosyn-HF (amino       ICU Medical, Inc., 600
                          acids) Injection, 8%.    North Field Dr., Lake
                                                   Forest, IL 60045.
ANDA 040723............  Isosorbide Dinitrate     Impax Laboratories,
                          Extended-Release         Inc., 30831 Huntwood
                          Tablets USP, 40          Ave., Hayward, CA
                          milligrams (mg).         94544.
ANDA 064062............  Amphotericin B for       Teva Parenteral
                          Injection USP, 50 mg/    Medicines, Inc., 19
                          vial.                    Hughes, Irvine, CA
                                                   92618.
ANDA 064200............  Cefotaxime for           Fresenius Kabi USA,
                          Injection USP,           LLC, Three Corporate
                          Equivalent to (EQ) 500   Dr., Lake Zurich, IL
                          mg base/vial, EQ 1       60047.
                          gram (g) base/vial,
                          and EQ 2 g base/vial.

[[Page 35655]]

 
ANDA 064201............  Cefotaxime for           Do.
                          Injection USP, EQ 10 g
                          base/vial and EQ 20 g
                          base/vial.
ANDA 065251............  Cefuroxime for           Samson Medical
                          Injection USP, EQ 75 g   Technologies, LLC,
                          base/bag and EQ 225 g    2050 Springdale Rd.,
                          base/bag (Pharmacy       P.O. Box 2730, Suite
                          Bulk Package).           400, Cherry Hill, NJ
                                                   08034.
ANDA 070892............  Metoclopramide           Norbrook Laboratories,
                          Hydrochloride (HCl)      Ltd., c/o Norbrook,
                          Injection, EQ 10 mg      Inc., 9401 Indian
                          base/2 milliliters       Creek Pkwy., Suite
                          (mL).                    680, Overland Park,
                                                   KS 66210.
ANDA 075309............  Ticlopidine HCl Tablets  Watson Laboratories,
                          USP, 250 mg.             Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 076797............  Risperidone Oral         Precision Dose, Inc.,
                          Solution USP, 1 mg/mL.   722 Progressive Lane,
                                                   South Beloit, IL
                                                   61080.
ANDA 077656............  Thrive (nicotine         GlaxoSmithKline
                          polacrilex) Gum USP      Consumer Healthcare,
                          (Chewable), EQ 4 mg      184 Liberty Corner
                          base.                    Rd., Suite 200,
                                                   Warren, NJ 07059.
ANDA 077658............  Thrive (nicotine         Do.
                          polacrilex) Gum USP
                          (Chewable), EQ 2 mg
                          base.
ANDA 080188............  Testosterone Propionate  Watson Laboratories,
                          Injection USP, 25 mg/    Inc., Subsidiary of
                          mL, 50 mg/mL, and 100    Teva Pharmaceuticals
                          mg/mL.                   USA, Inc.
ANDA 083398............  Prednisolone Acetate     Do.
                          Injectable Suspension,
                          25 mg/mL.
ANDA 083764............  Prednisolone Acetate     Do.
                          Injectable Suspension,
                          50 mg/mL.
ANDA 084072............  Triamcinolone Diacetate  Do.
                          Injection, 40 mg/mL.
ANDA 084270............  Triamcinolone Tablets    Do.
                          USP, 4 mg.
ANDA 084466............  Reserpine and            Do.
                          Hydrochlorothiazide
                          Tablets, 0.125 mg/25
                          mg.
ANDA 084604............  Procainamide HCl         Ivax Pharmaceuticals,
                          Capsules, 250 mg.        Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 085693............  Phentermine HCl Tablets  Sandoz, Inc., 4700
                          USP, 8 mg.               Sandoz Dr., Wilson,
                                                   NC 27893.
ANDA 085863............  Theophylline Elixir, 80  Precision Dose, Inc.
                          mg/15 mL.
ANDA 087185............  Ergoloid Mesylates       Ivax Pharmaceuticals,
                          Sublingual Tablets       Inc., Subsidiary of
                          USP, 1 mg.               Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087770............  Sulfinpyrazone Capsules  Do.
                          USP, 200 mg.
ANDA 088648............  Methotrexate Injection   Norbrook Laboratories,
                          USP, EQ 25 mg base/mL.   Ltd., c/o Norbrook,
                                                   Inc.
ANDA 088928............  Chlorzoxazone Tablets    Actavis Elizabeth,
                          USP, 250 mg.             LLC, Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 090663............  Gemcitabine for          Hameln RDS GmbH, c/o
                          Injection USP, EQ 200    B&H Consulting
                          mg base/vial and EQ 1    Services, Inc., 50
                          g base/vial.             Division St., Suite
                                                   206, Somerville, NJ
                                                   08876.
ANDA 091469............  Vancomycin HCl for       Mylan Laboratories,
                          Injection USP, EQ 10 g   Ltd., c/o Mylan
                          base/vial (Pharmacy      Pharmaceuticals,
                          Bulk Package).           Inc., 781 Chestnut
                                                   Ridge Rd., P.O. Box
                                                   4310, Morgantown, WV
                                                   26504.
ANDA 202390............  Tramadol HCl Tablets     Accord Healthcare,
                          USP, 50 mg.              Inc., 1009 Slater
                                                   Rd., Suite 210-B,
                                                   Durham, NC 27703.
ANDA 203506............  Oxymorphone HCl          Sun Pharmaceutical
                          Extended-Release         Industries, Ltd., c/o
                          Tablets, 5 mg, 7.5 mg,   Sun Pharmaceutical
                          10 mg, 15 mg, 20 mg,     Industries, Inc., 2
                          30 mg, and 40 mg.        Independence Way,
                                                   Princeton, NJ 08540.
ANDA 204320............  Olanzapine Orally        Ajanta Pharma, Ltd., c/
                          Disintegrating Tablets   o Ajanta Pharma USA,
                          USP, 5 mg, 10 mg, 15     Inc., 440 U.S.
                          mg, and 20 mg.           Highway 22 East, One
                                                   Grande Commons, Suite
                                                   150, Bridgewater, NJ
                                                   08807.
ANDA 204706............  Olopatadine HCl          Zambon S.p.A., c/o
                          Ophthalmic Solution      Camargo
                          USP, EQ 0.1% base.       Pharmaceutical
                                                   Services, LLC, 9825
                                                   Kenwood Rd., Suite
                                                   203, Cincinnati, OH
                                                   45242.
ANDA 207467............  Nevirapine Extended-     Technology Organized,
                          Release Tablets, 100     LLC, 9191 Point
                          mg and 400 mg.           Replete Dr., Fort
                                                   Belvoir, VA 22060.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
August 27, 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 August 27, 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: July 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16037 Filed 7-26-18; 8:45 am]
 BILLING CODE 4164-01-P


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