Document ID: FDA-2018-N-2180-0001
Agency: fda
Document Type: Notice
Title: Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New
Drug Applications
Posted Date: 2018-07-12T04:00Z

[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32305-32306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14935]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2180]

Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval 
of 29 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 29 new drug applications (NDAs) 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that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 13, 2018.

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 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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 011287.............  Kayexalate (sodium       Concordia
                          polystyrene sulfonate)   Pharmaceuticals,
                          Powder for Suspension,   Inc., c/o Mapi USA,
                          453.6 gram (g)/bottle.   Inc., 2343 Alexandria
                                                   Dr., Lexington, KY
                                                   40504.
NDA 012249.............  Librium                  Valeant
                          (chlordiazepoxide        Pharmaceuticals North
                          hydrochloride (HCl))     America, LLC, 400
                          Capsules, 5 milligram    Somerset Corporate
                          (mg), 10 mg, and 25 mg.  Blvd., Bridgewater,
                                                   NJ 08807.
NDA 016211.............  Miochol (acetylcholine   Novartis
                          chloride) for            Pharmaceuticals
                          Ophthalmic Solution,     Corp., One Health
                          20 mg/vial.              Pl., East Hanover, NJ
                                                   07936.
NDA 018674.............  Metro I.V.               B. Braun Medical,
                          (metronidazole)          Inc., 901 Marcon
                          Injection, 500 mg/100    Blvd., Allentown, PA
                          milliliter (mL).         18109.
NDA 018852.............  Sulfamethoxazole and     Watson Laboratories,
                          Trimethoprim Tablets     Inc., Subsidiary of
                          USP, 400 mg; 80 mg.      Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
NDA 018854.............  Sulfamethoxazole and     Do.
                          Trimethoprim Tablets
                          USP, 800 mg; 160 mg.
NDA 018988.............  Vasocidin (prednisolone  Novartis
                          sodium phosphate and     Pharmaceuticals Corp.
                          sulfacetamide sodium)
                          Ophthalmic Solution,
                          equivalent to (EQ)
                          0.23% phosphate/10%.
NDA 019844.............  Isolyte H in Dextrose    B. Braun Medical, Inc.
                          5% in Plastic
                          Container Injection.
NDA 019870.............  Isolyte M in Dextrose    Do.
                          5% in Plastic
                          Container Injection.
NDA 019964.............  Terazol 3 (terconazole)  Janssen
                          Vaginal Cream, 0.8%.     Pharmaceuticals,
                                                   Inc., 1125 Trenton-
                                                   Harbourton Rd.,
                                                   Titusville, NJ 08560.
NDA 020000.............  Dextrose 5% in Ringer's  B. Braun Medical, Inc.
                          in Plastic Container
                          Injection.
NDA 020393.............  Atrovent (ipratropium    Boehringer Ingelheim
                          bromide) Nasal Spray,    Pharmaceuticals,
                          0.021 mg/spray.          Inc., 900 Ridgebury
                                                   Rd., P.O. Box 368,
                                                   Ridgefield, CT 06877-
                                                   0368.
NDA 020394.............  Atrovent (ipratropium    Do.
                          bromide) Nasal Spray,
                          0.042 mg/spray.
NDA 021180.............  Ortho Evra (ethinyl      Janssen
                          estradiol;               Pharmaceuticals,
                          norelgestromin)          Inc., 1000 U.S. Route
                          Transdermal Patch,       202, P.O. Box 300,
                          0.035 mg/24 h; 0.15 mg/  Raritan, NJ 08869-
                          24 h.                    0602.
NDA 021633.............  Femtrace (estradiol      Allergan
                          acetate) Tablets, 0.45   Pharmaceuticals
                          mg, 0.9 mg, and 1.8 mg.  International, Ltd.,
                                                   c/o Allergan Sales,
                                                   LLC, 2525 Dupont Dr.,
                                                   Irvine, CA 92612.
NDA 022033.............  Luvox CR (fluvoxamine    Jazz Pharmaceuticals,
                          maleate) Extended-       Inc., 3180 Porter
                          Release Capsules, 100    Dr., Palo Alto, CA
                          mg and 150 mg.           94304.
NDA 022106.............  Doribax (doripenem) for  Shionogi, Inc., 300
                          Injection, 250 mg/vial   Campus Dr., Florham
                          and 500 mg/vial.         Park, NJ 07932.
NDA 022386.............  PrandiMet (metformin     Novo Nordisk, Inc.,
                          HCl; repaglinide)        P.O. Box 846,
                          Tablets, 500mg; 1 mg     Plainsboro, NJ 08536.
                          and 500 mg; 2 mg.
NDA 050201.............  Ophthocort               Parkedale
                          (chloramphenicol,        Pharmaceuticals,
                          hydrocortisone           Subsidiary of Pfizer
                          acetate, polymyxin B     Inc., 235 East 42nd
                          sulfate) Ophthalmic      St., New York, NY
                          Ointment USP, 10 mg/g;   10017.
                          5 mg/g; 10,000 units/g.
NDA 050344.............  Statrol (neomycin        Alcon Laboratories,
                          sulfate; polymyxin B     Inc., 6201 South
                          sulfate) Ophthalmic      Freeway, TC-45, Fort
                          Ointment, EQ 3.5 mg      Worth, TX 76134.
                          base/g; 10,000 units/g.
NDA 050442.............  Vibramycin (doxycycline  Pfizer, Inc., 235 East
                          hyclate) Injection, EQ   42nd St., New York,
                          to 200 mg base/vial      NY 10017.
                          and EQ 100 mg base/
                          vial.
NDA 050497.............  Ticar (ticarcillin       GlaxoSmithKline, 1250
                          disodium) Injection,     Collegeville Rd.,
                          EQ 1 g base/vial, EQ 3   Collegeville, PA
                          g base/vial, EQ 6 g      19426.
                          base/vial, EQ 20 g
                          base/vial, and EQ 30 g
                          base/vial.
NDA 050512.............  Duricef (cefadroxil      Warner Chilcott Co.,
                          monohydrate) USP         LLC, 100 Enterprise
                          Capsules, EQ 500 mg      Dr., Rockaway, NJ
                          base and EQ 250 mg       07866.
                          base.
NDA 050527.............  Duricef (cefadroxil      Do.
                          monohydrate) USP For
                          Oral Suspension, EQ
                          125 mg base/5 mL, EQ
                          250 mg base/5 mL, and
                          EQ 500 mg base/5 mL.
NDA 050593.............  Eryc Sprinkles           Hospira Inc., 275
                          (erythromycin)           North Field Dr., Lake
                          Capsules, 125 mg.        Forest, IL 60045.
NDA 050646.............  Ceptaz (ceftazidime)     GlaxoSmithKline.
                          Injection, 500 mg/
                          vial, 1 g/vial, 2 g/
                          vial, and 10 g/vial.
NDA 050668.............  Lorabid (loracarbef)     King Pharmaceuticals,
                          Capsules USP, 200 mg     Inc., 501 Fifth St.,
                          and 400 mg.              Bristol, TN 37620.
NDA 050792.............  Cefotaxime and Dextrose  B. Braun Medical, Inc.
                          2.4% in Plastic
                          Container, EQ 2 g
                          base, and Cefotaxime
                          and Dextrose 3.9% in
                          Plastic Container, EQ
                          1 g base.

[[Page 32306]]

 
NDA 050807.............  Epirubicin HCl for       Hospira, Inc.
                          Injection, 50 mg/vial,
                          200 mg/vial.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
August 13, 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 13, 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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14935 Filed 7-11-18; 8:45 am]
 BILLING CODE 4164-01-P