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Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 103 new drug applications (NDAs) and 35 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective March 13, 2009.

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Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-796-3601.

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The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing.

Application No.DrugApplicant
NDA 7-335Pronestyl (procainamide hydrochloride (HCl)) Capsules and InjectionApothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000
NDA 7-935Phenergan (promethazine HCl) TabletsWyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 9-193Cogentin (benztropine mesylate) TabletsMerck & Co., Inc., Sunneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486
NDA 9-986Deltasone (prednisone) TabletsPharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York, NY 10017
NDA 10-374Medihaler-Epi (epinephrine bitartrate)3M Pharmaceuticals, 3M Center, Bldg. 0275-05-W-12, St. Paul, MN 55144-1000
NDA 10-375Medihaler-ISO (isoproterenol)Do.
NDA 10-598Bendectin (doxylamine succinate and pyridoxine HCl) TabletsSanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807-0977
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NDA 10-796Harmonyl (deserpidine) TabletsAbbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60064-6154
NDA 10-800Tralgon (acetaminophen) ElixirBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000
NDA 10-927Phosphotope (sodium phosphates solution USP) Oral SolutionBracco Diagnostics, P.O. Box 5225, Princeton, NJ 08543-5225
NDA 10-928Aureotope (gold injection)Do.
NDA 11-161Aristocort (triamcinolone) TabletsAstellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2537
NDA 11-467Trancopal (chlormezanone) TabletsSanofi-Aventis
NDA 11-721Neptazane (methazolamide) TabletsLederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 11-751Prolixin (fluphenazine HCl) Injection and TabletsApothecon, c/o Bristol-Myers Squibb Co.
NDA 11-832Vasodilan (isoxsuprine HCl)Do.
NDA 12-097Kenalog in Orabase (triamcinolone acetonide dental paste USP)Do.
NDA 12-164Naturetin (bendroflumethiazide USP), 2.5 milligrams (mg), 5 mg, and 10 mgDo.
NDA 12-515Kenacort (tramcinolone diacetate) SyrupBristol-Meyers Squibb Co.
NDA 13-296Duo-Medihaler (phenyleprine bitartrate and isoproterenol HCl)3M Pharmaceuticals
NDA 13-601Mucomyst (acetylcysteine solution USP)Apothecon, c/o Bristol-Myers Squibb Co.
NDA 14-715Triavil (perphenazine and amitriptyline HCl) TabletsNew River Pharmaceuticals, Inc., 2200 Kraft Dr., suite 2050, Blacksburg, VA 24060
NDA 15-419Hipputope (iodohippurate sodium I-131 injection USP)Bracco Diagnostics
NDA 16-033Vontrol (diphenidol HCl) Tablets, 25 mgGlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709
NDA 16-090Rubratope-60 (cyanocobalamin CO-60)Bracco Diagnostics
NDA 16-224Robengatope (rose bengal sodium I-131 injection USP)Do.
NDA 16-727Prolixin Decanoate (fluphenazine decanoate) InjectionBristol-Myers Squibb Co.
NDA 16-783Vascoray (iothalamate meglumine, 52% and iothalamate sodium, 26% injection)Tyco Healthcare/Mallinckrodt Inc., P.O. Box 5840, St. Louis, MO 63134-0840
NDA 16-906Technetope II (technetium Tc-99m sodium pertechnetate sterile generatorBracco Diagnostics
NDA 16-923Tesuloid (technetium Tc-99m sulfur colloid kit)Do.
NDA 16-929FUDR (floxuridine) Injection, 500 mg/5 milliliters (mL)Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046
NDA 16-996Hyperstat (diazoxide) InjectionSchering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 17-024Strotope (strontium nitrate Sr-85) InjectionBracco Diagnostics
NDA 17-045Renotec (technetium Tc-99m ferpenetate kit)Do.
NDA 17-047Sethotope (selenomethionine Se-75) InjectionDo.
NDA 17-269Chlormerodrin Hg-197 InjectionDo.
NDA 17-339Minitec (technetium Tc-99m sodium pertechnetate generator)Do.
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NDA 17-371Pronestyl (procainamide HCl) TabletsApothecon, c/o Bristol-Myers Squibb Co.
NDA 17-395Intropin (dopamine HCl) Injection, 40 mg/mL, 80 mg/mL, and 160 mg/mLHospira, Inc.
NDA 17-598Septra (trimethoprim and sulfamethoxazole) Oral SuspensionMonarch Pharmaceutcals, Inc., 501 5th St., Bristol, TN 37620
NDA 17-685Conray 325 (iothalamate sodium)Mallinckrodt Inc., 675 McDonnell Blvd., P.O. Box 5840, St. Louis, MO 63134
NDA 17-787Radionuclide-Labeled (I-125) Fibrinogen SensorAbbott Laboratories
NDA 17-834Albumotope-LS (albumin aggregated iodinated I-131-serum)Bracco Diagnostics
NDA 17-902Renovue-65 (iodamide meglumine) Injection, 65%Do.
NDA 17-903Renovue-Dip (iodamide meglumine) InjectionDo.
NDA 17-931Iletin I (insulin pork)Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 17-932Protamine Zinc and Iletin I (insulin suspension protamine zinc beef/pork)Do.
NDA 17-935Ultralente Iletin I (insulin zinc suspension extended beef/pork)Do.
NDA 17-936NPH Iletin I (insulin suspension isophane beef/pork)Do.
NDA 17-943Proloprin (trimethoprim) Tablets, 100 mg and 200 mgMonarch Pharmaceuticals, Inc.
NDA 17-970Nolvadex (tamoxifen citrate) TabletsAstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355
NDA 17-979Heparin Sodium Injection USPAbraxis Pharmaceutical Products, Riverway One, 6133 North River Rd., suite 500, Rosemont, IL 60018
NDA 18-017Blocadren (timolol maleate) TabletsMerck & Co., Inc., UG2C-50, P.O. Box 1000, North Wales, PA 19454-1099
NDA 18-061Timolide (timolol maleate and hydrochorothiazide) Tablets, 10 mg/25mgDo.
NDA 18-076Cholovue (iodoxamate meglumine) Injection, 40.3%Bracco Diagnostics
NDA 18-077Cholovue (iodoxamate meglumine) for InfusionDo.
NDA 18-116Cyclocort (amcinonide) Cream, 0.1%Astellas Pharma US, Inc.
NDA 18-211Ditropan (oxybutynin chloride) Syrup, 5 mgOrtho-McNeil-Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, P.O. Box 3000, Raritan, NJ 08869-0602
NDA 18-344Iletin II (insulin purified pork)Eli Lilly & Co.
NDA 18-345NPH Iletin II (insulin suspension isophane purified pork)Do.
NDA 18-346Protamine, Zinc, and Iletin II (insulin suspension protamine zinc purified pork)Do.
NDA 18-347Lente Iletin II (insulin zinc suspension purified pork)Do.
NDA 18-354Ortho-Novum 10/11-21 and 10/11-28 (norethindrone and ethinyl estradiol) TabletsOrtho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, 920 Rt. 202 South, P.O. Box 300, Raritan, NJ 08869
NDA 18-452Septra (sulfamethoxazole and trimethorprim) InjectionMonarch Pharmaceuticals, Inc.
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NDA 18-476Protamine, Zinc, and Iletin II (insulin suspension protamine zinc purified beef)Eli Lilly & Co.
NDA 18-477Lente Iletin II (insulin zinc suspension purified beef)Do.
NDA 18-478Regular Iletin II (insulin purified beef)Do.
NDA 18-479NPH Iletin II (insulin suspension isophane purified beef)Do.
NDA 18-498Cyclocort (amcinonide) Ointment, 0.1%Astellas Pharma US, Inc.
NDA 18-537Tridil (nitroglycerin) InjectionHospira, Inc.
NDA 18-831Tracrium (atracurium besylate) InjectionHospira, Inc.
NDA 18-873Mexitil (mexiletine HCl) Capsules, 150 mg, 200 mg, and 250 mgBoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368
NDA 18-922Lodine (etodolac) Capsules and TabletsWyeth Pharmaceuticals, Inc.
NDA 19-085Atrovent (ipratropium bromide) AerosolBoehringer Ingelheim Pharmaceuticals, Inc.
NDA 19-166Regular Insulin (insulin zinc suspension beef) InjectionEli Lilly & Co.
NDA 19-167NPH Insulin Beef (insulin zinc suspension beef)Do.
NDA 19-529Humulin BR (insulin recombinant human)Do.
NDA 19-729Cyclocort (amcinonide) Lotion, 0.1%Astellas Pharma US, Inc.
NDA 19-816Oruvail (ketoprofen) Extended-Release CapsulesWyeth Pharmaceuticals, Inc.
NDA 19-890Stadol (butorphanol tartrate) Nasal SprayBristol-Myers Squibb Co.
NDA 19-965Novolin L (insulin zinc suspension recombinant human)Novo Nordisk, Inc., 100 College Road West, Princeton, NJ 08540
NDA 20-152Serzone (nefazodone HCl) TabletsBristol-Myers Squibb Co.
NDA 20-219Livostin (levocabastine HCl) Ophthalmic Suspension, 0.05%Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080
NDA 20-225Indur (isosorbide mononitrate) Extended-Release Tablets, 30 mg, 60 mg, and 120 mgSchering Corp.
NDA 20-326Neutrexin (trimetrexate glucuronate) Injection, 25 mg and 200 mg vialsMedImmune Oncology, Inc., One MedImmune Way, Gaithersburg, MD 20878
NDA 20-377Cordarone (amiodarone HCl), Injection, 50 mg/mLWyeth Pharmaceuticals, Inc.
NDA 20-429Orudis KT (ketoprofen) Tablets, 12.5 mgWyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940
NDA 20-584Lodine XL (etodolac) Extended-Release TabletsWyeth Pharmaceuticals, Inc.
NDA 20-698MiraLax (polyethylene glycol 3350) Powder for SolutionBraintree Laboratories, Inc., 60 Columbian Street West, P.O. Box 850929, Braintree, MA 02185-0929
NDA 20-784Nasacort HFA (triamcinolone acetonide) Nasal SpraySanofi-Aventis
NDA 20-974Prozac (fluoxetine HCl) TabletsEli Lilly & Co.
NDA 21-028Velosulin BR (insulin recombinant injection)Novo Nordisk, Inc.
NDA 21-369Codeprex (codeine polistirex and chlorpheniramine polistirex) Extended-Release SuspensionUCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080
NDA 21-387Pravigard Pak (copackaged) (pravastatin sodium and aspirin) TabletsBristol-Meyers Squibb Co.
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ANDA 40-305Meperidien HCl Injection USP, 10 mg/mLHospira, Inc.
NDA 50-155Chloromycetin Sodium Succinate (chloramphenicol sodium succinate for injection USP)Parkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620
NDA 50-205Chloromycetin (chloramphenicol) Otitic SolutionDo.
NDA 50-285Mycifradin (neomycin sulfate) Oral SuspensionPharmacia & Upjohn Co., c/o Pfizer, Inc.
NDA 50-339Albamycin (novobiocin sodium) CapsulesDo.
NDA 50-435Geocillin (carbenicillin indanyl sodium) Tablets, 382 mgPfizer, Inc., 235 East 42d St., New York, NY 10017
NDA 50-504Mandol (cefamandole nafate) InjectionEli Lilly & Co.
NDA 50-589Cefizox (ceftizoxime sodium)Astellas Pharma US, Inc.
NDA 50-621Suprax (cefixime) Tablets, 200 mg and 400 mgLederle Laboratories, c/o Wyeth Pharmaceuticals, Inc.
NDA 50-622Suprax (cefixime) Powder for SuspensionDo.
ANDA 60-591Chloromycetin (chloramphenicol capsules USP), 50 mg, 100 mg, and 250 mgParkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc.
ANDA 61-922Vidarabine Monohydrate Micronized Powder, SterileDo.
ANDA 62-655Tazidime (ceftazidime for injection USP)Eli Lilly & Co.
ANDA 63-350Amikacin Sulfate Injection USP, 50 mg base/mL and 250 mg base/mLHospira, Inc.
ANDA 70-847Metoclopramide Injection USP, 5 mg base/mLHospira, Inc.
ANDA 71-291Metoclopramide Injection USP, 5 mg base/mLDo.
ANDA 71-364Acetylcysteine Solution USPDo.
ANDA 71-365Acetylcysteine Solution USPDo.
ANDA 71-645Droperidol Injection USP, 2.5 mg/mLDo.
ANDA 73-272Albuterol Inhalation AerosolIVAX Pharmaceuticals Ireland, c/o IVAX Pharmaceuticals, Inc., Two University Plaza, suite 220, Hackensack, NJ 07601
ANDA 74-966Fluphenazine Decanoate Injection, 25 mg/mLHospira, Inc.
ANDA 75-106Diltiazem HCl Injection, 5 mg/mLDo.
ANDA 75-242Labetalol HCL Injection, 5 mg/mLDo.
ANDA 75-342Butorphanol Tartrate Injection USP, 1 mg/mL and 2mg/mLDo.
ANDA 75-396Midazolam HCl InjectionDo.
ANDA 75-484Midazolam HCl Injection, 5 mg base/mLDo.
ANDA 75-571Enalaprilat Injection, 1.25 mg/mLDo.
ANDA 75-669Famotidine Injection, 10 mg/mLDo.
ANDA 75-705Famotidine Injection, 10 mg/mLDo.
ANDA 75-816Calcitriol InjectionDo.
ANDA 75-830Milrinone Lactate Injection, 1 mg base/mLDo.
ANDA 75-108Amiodarone HCl Injection, 50 mg/mLDo.
ANDA 76-233Paclitaxel InjectionDo.
ANDA 76-473Carboplatin for Injection USPDo.
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ANDA 76-978Ondansetron HCl and Dextrose InjectionDo.
ANDA 77-362Amlodipine Besylate TabletsKing and Spalding, U.S. Agent for Genpharm Inc., 1700 Pennsylvania Ave., NW., Washington, DC 20006-4706
ANDA 77-925Meloxicam Tablets, 7.5 mg and 15 mgRoxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228
ANDA 85-153Alkergot (ergoloid mesylates) Sublingual Tablets, 0.5 mgSandoz, Inc., 227-15 North Conduit Ave., Laurelton, NY 11413
ANDA 85-916Diethylpropion HCl Tablets, 25 mgDo.
ANDA 86-172Meclizine HCl Tablets, 12.5 mgDo.
ANDA 86-174Meclizine HCl Tablets, 25 mgDo.
ANDA 86-184Sulfasalazine Tablets, 500 mgDo.
ANDA 87-417Alkergot (ergoloid mesylates) Sublingual Tablets, 1 mgDo.
ANDA 89-565Vinblastine Sulfate Injection, 10 mg/vialHospira, Inc.

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective March 13, 2009.

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Dated: January 12, 2009.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. E9-2901 Filed 2-10-09; 8:45 am]