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Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications

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Food and Drug Administration, HHS.




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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of August 13, 2018.

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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.

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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 § 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 § 314.150(c) is without prejudice to refiling.

Application No.DrugApplicant
NDA 011287Kayexalate (sodium polystyrene sulfonate) Powder for Suspension, 453.6 gram (g)/bottleConcordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria Dr., Lexington, KY 40504.
NDA 012249Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram (mg), 10 mg, and 25 mgValeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 016211Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vialNovartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936.
NDA 018674Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL)B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109.
NDA 018852Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mgWatson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
NDA 018854Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mgDo.
NDA 018988Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium) Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%Novartis Pharmaceuticals Corp.
NDA 019844Isolyte H in Dextrose 5% in Plastic Container InjectionB. Braun Medical, Inc.
NDA 019870Isolyte M in Dextrose 5% in Plastic Container InjectionDo.
NDA 019964Terazol 3 (terconazole) Vaginal Cream, 0.8%Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560.
NDA 020000Dextrose 5% in Ringer's in Plastic Container InjectionB. Braun Medical, Inc.
NDA 020393Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/sprayBoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368.
NDA 020394Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/sprayDo.
NDA 021180Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch, 0.035 mg/24 h; 0.15 mg/24 hJanssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300, Raritan, NJ 08869-0602.
NDA 021633Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mgAllergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612.
NDA 022033Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg and 150 mgJazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304.
NDA 022106Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vialShionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932.
NDA 022386PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500 mg; 2 mgNovo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536.
NDA 050201Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sulfate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/gParkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 050344Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, EQ 3.5 mg base/g; 10,000 units/gAlcon Laboratories, Inc., 6201 South Freeway, TC-45, Fort Worth, TX 76134.
NDA 050442Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial and EQ 100 mg base/vialPfizer, Inc., 235 East 42nd St., New York, NY 10017.
NDA 050497Ticar (ticarcillin disodium) Injection, EQ 1 g base/vial, EQ 3 g base/vial, EQ 6 g base/vial, EQ 20 g base/vial, and EQ 30 g base/vialGlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426.
NDA 050512Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and EQ 250 mg baseWarner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866.
NDA 050527Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mLDo.
NDA 050593Eryc Sprinkles (erythromycin) Capsules, 125 mgHospira Inc., 275 North Field Dr., Lake Forest, IL 60045.
NDA 050646Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/vialGlaxoSmithKline.
NDA 050668Lorabid (loracarbef) Capsules USP, 200 mg and 400 mgKing Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
NDA 050792Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g baseB. Braun Medical, Inc.
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NDA 050807Epirubicin HCl for Injection, 50 mg/vial, 200 mg/vialHospira, Inc.

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.

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Dated: July 9, 2018.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2018-14935 Filed 7-11-18; 8:45 am]