Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2018-N-2180]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of August 13, 2018.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 § 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.
Drug
ApplicantNDA 011287
Kayexalate (sodium polystyrene sulfonate) Powder for Suspension, 453.6 gram (g)/bottle
Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria Dr., Lexington, KY 40504.NDA 012249
Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram (mg), 10 mg, and 25 mg
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.NDA 016211
Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vial
Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936.NDA 018674
Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL)
B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109.NDA 018852
Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.NDA 018854
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mg
Do.NDA 018988
Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium) Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%
Novartis Pharmaceuticals Corp.NDA 019844
Isolyte H in Dextrose 5% in Plastic Container Injection
B. Braun Medical, Inc.NDA 019870
Isolyte M in Dextrose 5% in Plastic Container Injection
Do.NDA 019964
Terazol 3 (terconazole) Vaginal Cream, 0.8%
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560.NDA 020000
Dextrose 5% in Ringer's in Plastic Container Injection
B. Braun Medical, Inc.NDA 020393
Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/spray
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368.NDA 020394
Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/spray
Do.NDA 021180
Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch, 0.035 mg/24 h; 0.15 mg/24 h
Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300, Raritan, NJ 08869-0602.NDA 021633
Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mg
Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612.NDA 022033
Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg and 150 mg
Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304.NDA 022106
Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vial
Shionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932.NDA 022386
PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500 mg; 2 mg
Novo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536.NDA 050201
Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sulfate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/g
Parkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.NDA 050344
Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, EQ 3.5 mg base/g; 10,000 units/g
Alcon Laboratories, Inc., 6201 South Freeway, TC-45, Fort Worth, TX 76134.NDA 050442
Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial and EQ 100 mg base/vial
Pfizer, Inc., 235 East 42nd St., New York, NY 10017.NDA 050497
Ticar (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/vial
GlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426.NDA 050512
Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and EQ 250 mg base
Warner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866.NDA 050527
Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL
Do.NDA 050593
Eryc Sprinkles (erythromycin) Capsules, 125 mg
Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045.NDA 050646
Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/vial
GlaxoSmithKline.NDA 050668
Lorabid (loracarbef) Capsules USP, 200 mg and 400 mg
King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.NDA 050792
Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base
B. Braun Medical, Inc.( print page 32306)NDA 050807
Epirubicin HCl for Injection, 50 mg/vial, 200 mg/vial
Hospira, 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. 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