AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 80 new drug applications (NDAs) and 75 abbreviated new drug applications (ANDAs). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 DATE:
September 17, 2003
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
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. | Drug | Applicant |
|---|---|---|
| NDA 0-159 | Sulfapyridine Tablets. | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 0-734 | Histamine Phosphate Injection. | Do. |
| NDA 5-970 | Sotradecol (sodium tetradecyl sulfate) Injection. | Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299. |
| NDA 7-898 | Benemid (probenecid) Tablets. | Merck & Co., Inc., Sunneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486. |
| NDA 8-048 | Xylocaine (lidocaine) Ointment. | AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355. |
| NDA 8-228 | Hydrocortone (hydrocortisone acetate) Acetate Injectable Suspension. | Merck & Co., Inc. |
| NDA 8-565 | Thiosulfil (sulfamethizole) Tablets and Suspension. | Wyeth Pharmaceuticals. |
| NDA 9-489 | Pathilon (tridehixethyl) Tablets. | Lederle Laboratories, P.O. Box 8299, Philadelphia, PA 19101-8299. |
| NDA 10-210 | Metymid Ophthalmic (prednisolone acetate and sulfacetamide sodium). | Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. |
| NDA 10-220 | Hypaque-M 75% and 90% Hypague Compound (diatrizoate meglumine and diatrizoate sodium) Injection. | Amersham Health, 101 Carnegie Center, Princeton, NJ 08540-6231. |
| NDA 10-348 | Sparine (promazine hydrochloride (HCl)) Tablets. | Wyeth Pharmaceuticals. |
| NDA 10-496 | Xylocaine-MPF 5% Solution With Glucose 7.5% (lidocaine HCl and dextrose). | AstraZeneca Pharmaceuticals LP. |
| NDA 10-562 | Hydeltra-T.B.A. (prednisolone tebutate). | Merck & Co., Inc. |
| NDA 10-753 | Estradurin (polyestradiol phosphate) Injection. | Wyeth Pharmaceuticals. |
| NDA 10-942 | Sparine (promazine HCl) Syrup and Concentrate. | Do. |
| NDA 11-338 | Fluothane Inhalation (halothane USP). | Do. |
| NDA 11-418 | Dimetane Ten Injectable (brompheniramine maleate). | Do. |
| NDA 11-673 | Tepanil (diethylpropion HC1) Tablets. | 3M Pharmaceuticals, 3M Center, Bldg. 270-3A-01, St. Paul, MN 55144-1000. |
| NDA 11-958 | Hydropres (reserpine and hydrochlorothiazide). | Merck & Co., Inc. |
| NDA 12-383 | ColBenemid (probenecid and colchicine) Tablets. | Do. |
| NDA 12-418 | Akineton (biperiden lactate) Injection. | Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60064-6157. |
| NDA 12-489 | Exna (benzthiazide) Tablets. | Wyeth Pharmaceuticals. |
| NDA 12-731 | Decaspray (dexamethasone) Topical Aerosol. | Merck & Co., Inc. |
| NDA 12-882 | Isordil Tembids (isosorbide dinitrate) Controlled-Release Tablets and Capsules. | Wyeth Pharmaceuticals. |
| NDA 12-947 | Artane (trihexyphenidyl HCl) Sustained-Release Capsules. | Lederle Laboratories. |
| NDA 13-264 | Hydromox (quinethazone) Tablets. | Wyeth Pharmaceuticals. |
| NDA 13-334 | Decadron With Xylocaine Injection (dexamethasone sodium phosphate and lidocaine HCl). | Merck & Co., Inc. |
| NDA 13-378 | Dymelor (acetohexamide) Tablets. | Eli Lilly and Co. |
| NDA 13-731 | Bilopaque (tyropanoate sodium) Capsules. | Amersham Health. |
| NDA 14-763 | Citanest Plain (prilocaine HCl) and Citanest Forte (prilocaine HCl and epinephrine) Injection. | AstraZeneca Pharmaceuticals LP. |
| NDA 15-052 | Atabrine (quinacrine HCl) Injection. | Abbott Laboratories. |
| NDA 15-921 | Haldol (haloperidol) Tablets. | Ortho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, L.L.C., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560-0200. |
| NDA 15-922 | Haldol (haloperidol lactate) Oral Concentrate. | Do. |
| NDA 16-192 | Sorbitrate (isosorbide dinitrate) Oral 5 milligram (mg) and 10 mg Tablets. | AstraZeneca Pharmaceuticals LP. |
| NDA 16-675 | Decadron LA (dexamethasone acetate) Sterile Suspension. | Merck & Co., Inc. |
| NDA 16-776 | Sorbitrate (isosorbide dinitrate) Chewable Tablets. | AstraZeneca Pharmaceuticals LP. |
| NDA 17-048 | Peptavlon (pentagastrin) for Subcutaneous Injection. | Wyeth Pharmaceuticals. |
| NDA 17-406 | Dicopac Kit. | Amersham Health. |
| NDA 17-503 | Combipres (clonidine HCl and chlorthalidone) Tablets. | Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368. |
| NDA 17-638 | Thypinone (protirelin) Injection. | Abbott Laboratories. |
| NDA 17-653 | Technetium Tc-99m HEDSPA Multidose Kit. | Amersham Health. |
| NDA 17-691 | Diprosone (betamethasone dipropionate) Ointment, 0.05%. | Schering Corp. |
| NDA 17-751 | Duranest (etidocaine HCl) Injection. | AstraZeneca Pharmaceuticals LP. |
| NDA 17-775 | Technetium Tc-99m HSA Kit. | Medi-Physics, Inc., d.b.a., Nycomed Amersham Imaging, 101 Carnegie Center, Princeton, NJ 08540-6231. |
| NDA 17-784 | Technetium Tc-99m TSC Kit. | Amersham Health. |
| NDA 17-980 | Mazanor (mazindol) Tablets. | Wyeth Pharmaceuticals. |
| NDA 17-982 | Amipaque (metrizamide) Injection. | Amersham Health. |
| NDA 17-992 | Crescormon (somatropin, pituitary). | Genentech, Inc., 1 DNA Way, MS#48, South San Francisco, CA 94080-4990. |
| NDA 18-021 | Asendin (amoxapine) 25 mg, 50 mg, 100 mg, and 150 mg Tablets. | Wyeth Pharmaceuticals. |
| NDA 18-153 | Beclovent (beclomethasone dipropionate) Inhalation Aerosol. | GlaxoSmithKline, Five Moore Dr., Research Triangle Park, NC 27709. |
| NDA 18-280 | Yutopar (ritodrine HCl) Tablets and Injection. | Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. |
| NDA 18-290 | Secretin-Ferring Powder for Injection. | Ferring Pharmaceuticals, Inc., 120 White Plains Rd., Suite 400, Tarrytown, NY 10591. |
| NDA 18-381 | Regular Purified Pork Insulin. | Novo Nordisk Pharmaceuticals, Inc., 100 College Rd. West, Princeton, NJ 08540. |
| NDA 18-383 | Lente Purified Pork Insulin Zinc Supension. | Do. |
| NDA 18-450 | Nitropress (sodium nitroprusside) Injection. | Abbott Laboratories. |
| NDA 18-623 | NPH Purified Pork Isophane Insulin Suspension. | Novo Nordisk Pharmaceuticals, Inc. |
| NDA 19-112 | Ventolin (albuterol sulfate) Tablets. | GlaxoSmithKline. |
| NDA 19-269 | Ventolin (albuterol sulfate) Inhalation Solution, 0.5%. | Do. |
| NDA 19-280 | Cyklokapron (tranexamic acid) Tablets. | Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199. |
| NDA 19-489 | Ventolin (albuterol sulfate) Rotacaps Inhalation Powder. | GlaxoSmithKline. |
| NDA 19-536 | Inderal (propranolol HCl) Oral Suspension. | Wyeth Pharmaceuticals. |
| NDA 19-773 | Ventolin (albuterol sulfate) Nebules Inhalation Solution, 0.083%. | GlaxoSmithKline. |
| NDA 19-836 | Supprelin (histrelin acetate) Injection. | Shire Pharmaceutical Development, Inc., 1801 Research Blvd., Suite 600, Rockville, MD 20850. |
| NDA 20-063 | Technetium Tc-99m Red Blood Cell Kit. | Cadema Corp., c/o Number One Corporation, 50 Washington St., Norwalk, CT 06854. |
| NDA 20-924 | Cernevit-12 Multivitamins. | Baxter Healthcare Corp., Route 120 and Wilson Rd., RLT-10, Round Lake, IL 60073-0490. |
| NDA 21-384 | Duranest (etidocaine HCl and epinephrine bitartrate) Injection. | Dentsply Pharmaceutical, 3427 Concord Rd., York, PA 17402. |
| NDA 50-202 | Chloromycetin Hydrocortisone Ophthalmic (chloramphenicol and hydrocortisone acetate for ophthalmic suspension USP). | Parkdale Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620. |
| NDA 50-251 | Aureomycin (chlortetracycline HCl) Capsules. | Wyeth Pharmaceuticals. |
| NDA 50-257 | Declomycin (demeclocycline HCl) Syrup Drops. | Do. |
| NDA 50-263 | Achromycin V (tetracycline HCl) Suspension and Drops. | Do. |
| NDA 50-264 | Achromycin (tetracycline HCl). | Do. |
| NDA 50-315 | Minocin (minocycline HCl) Capsules. | Do. |
| NDA 50-451 | Minocin (minocycline HCl) Tablets. | Do. |
| NDA 50-483 | Nebcin (tobramycin sulfate) Sensitivity Disk. | Eli Lilly and Co. |
| NDA 50-484 | Cerubidine (daunorubicin HCl) Injection. | Wyeth Pharmaceuticals. |
| NDA 50-493 | Topicycline (tetracycline HCl) Solution. | Shire Pharmaceutical Development, Inc. |
| NDA 50-508 | Cyclapen-W (cyclacillin) Oral Suspension. | Wyeth Pharmaceuticals. |
| NDA 50-509 | Cyclapen-W (cyclacillin) Tablets. | Do. |
| NDA 50-544 | Netromycin (netilmicin sulfate) Injection. | Schering Corp. |
| NDA 50-633 | Cefpiramide Sodium Injection. | Wyeth Pharmaceuticals. |
| ANDA 60-007 | Pen-Vee K for Oral Solution (penicillin V potassium for oral solution), 125 mg (base)/5 milliliters (mL) and 250 mg (base)/5 mL. | Do. |
| ANDA 60-462 | Garamycin (gentamicin sulfate) Cream, 0.1%. | Schering Corp. |
| ANDA 61-151 | Nilstat (nystatin) tablets USP) Oral Tablets, 500,000 units. | Lederle Laboratories. |
| ANDA 61-325 | Nilstat (nystatin) Vaginal Tablets, 100,000 units. | Do. |
| ANDA 61-444 | Nilstat (nystatin) Ointment, 100,000 units/gram (g). | Do. |
| ANDA 61-445 | Nilstat (nystatin) Cream, 100,000/g. | Do. |
| ANDA 61-633 | Robimycin (erythromycin) Robitabs, 250 mg. | A.H. Robins Co., P.O. Box 8299, Philadelphia, PA 19101-8299. |
| ANDA 61-734 | Robitet (tetracycline HCl capsules USP) Robicaps, 250 mg and 500 mg. | Wyeth Pharmaceuticals. |
| ANDA 62-120 | Wymox (amoxicillin) Capsules, 250 mg and 500 mg. | Do. |
| ANDA 62-302 | Otobiotic (polymyxin B sulfate and hydrocortisone otic solution USP) Sterile Otic Solution. | Schering Corp. |
| ANDA 62-579 | Precef (ceforanide) for Injection. | Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500. |
| ANDA 62-821 | Cephalexin Capsules USP, 250 mg. | TEVA Pharmaceutical USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454. |
| ANDA 62-823 | Cephalexin Capsules USP, 500 mg. | TEVA Pharmaceutical USA. |
| ANDA 62-860 | Ampicillin for Injection. | Apothecon. |
| ANDA 62-867 | Cephalexin for Oral Suspension USP, 250 mg/5mL. | TEVA Pharmaceutical USA. |
| ANDA 62-873 | Cephalexin for Oral Suspension USP, 125 mg/5mL. | Do. |
| ANDA 62-961 | Cefadyl (cephapirin) for Injection. | Apothecon. |
| ANDA 63-120 | Tobramycin Sulfate Injection USP, 2 mL vial, 40 mg/mL. | AstraZeneca LP. |
| ANDA 63-122 | Tobramycin Sulfate Injection USP, 40 mg/mL. | Do. |
| ANDA 64-131 | Trimox (amoxicillin tablets USP), Tablets, 125 mg and 250 mg. | Apothecon. |
| ANDA 70-128 | Propranolol HCl Tablets USP, 80 mg. | ESI Lederle, c/o Lederle Laboratories, 401 North Middletown Rd., Pearl River, NY 10965-1299. |
| ANDA 70-318 | Haloperidol Oral Solution USP (Concentrate), 2 mg/mL. | Alpharma, U.S. Pharmaceuticals Division, 200 Elmora Ave., Elizabeth, NJ 07207. |
| ANDA 70-757 | Propranolol HCl Tablets USP, 80 mg. | Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207. |
| ANDA 70-814 | Propranolol HCl Tablets USP, 10 mg. | Do. |
| ANDA 70-815 | Propranolol HCl Tablets USP, 20 mg. | Do. |
| ANDA 70-816 | Propranolol HCl Tablets USP, 40 mg. | Do. |
| ANDA 70-817 | Propranolol HCl Tablets USP, 60 mg. | Do. |
| ANDA 71-495 | Propranolol HCl Tablets USP, 60 mg. | ESI Lederle. |
| ANDA 71-496 | Propranolol HCl Tablets USP, 90 mg. | Do. |
| ANDA 71-673 | Doxepin HCl Capsules USP, 50 mg. | Do. |
| ANDA 71-674 | Doxepin HCl Capsules USP, 75 mg. | Do. |
| ANDA 71-675 | Doxepin HCl Capsules USP, 100 mg. | Do. |
| ANDA 71-676 | Doxepin HCl Capsules USP, 150 mg. | Do. |
| ANDA 71-685 | Doxepin HCl Capsules USP, 10 mg. | Do. |
| ANDA 71-686 | Doxepin HCl Capsules USP, 25 mg. | Do. |
| ANDA 72-026 | Fentanyl Citrate and Droperidol Injection. | AstraZeneca LP. |
| ANDA 72-687 | Foamicon (alumina and magnesium trisilicate tablets USP), 80 mg and 20 mg. | Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054-0622. |
| ANDA 73-080 | Loperamide HCl Capsules USP, 2mg. | Roxane Laboratoires, Inc., P.O. Box 16532, Columbis, OH 43216. |
| ANDA 73-403 | Questran (cholestyramine) Tablets, 800 mg and 1,000 mg. | Bristol-Myers Squibb Co. |
| ANDA 73-440 | Desoximetasone Ointment USP, 0.25%. | Altana, Inc., 60 Baylis Rd., Melville, NY 11747. |
| ANDA 73-494 | Thiothixene HCl Intensol Oral Solution (Concentrate), 5 mg/mL. | Roxane Laboratories, Inc. |
| ANDA 74-036 | Piroxicam Capsules USP, 10 mg and 20 mg. | SCS Pharmaceuticals, Box 5110, Chicago, IL 60680-9889. |
| ANDA 74-734 | Iopamidol Injection USP, 61% and 76%. | Faulding Pharmaceuticals, Mack-Cali Centre 11, 650 From Rd., Paramus, NJ 07652. |
| ANDA 75-100 | Bromocriptine Mesylate Capsules USP, 5 mg. | Lek, Pharmaceutical and Chemical Co. d.d., c/o Lek Services, Inc., 115 North Third St., Suite 301, Wilmington, NC 28401. |
| ANDA 75-223 | Labetalol HCl Tablets USP, 100 mg, 200 mg, and 300 mg. | Apothecon. |
| ANDA 80-081 | Sulfadiazine Tablets USP, 500 mg. | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| ANDA 80-254 | Testosterone Propionate Injection USP, 50 mg/mL. | Eli Lilly and Co. |
| ANDA 80-686 | Folic Acid Tablets USP, 1 mg. | Impax Laboratories, Inc. |
| ANDA 80-781 | Hydrocortisone Tablets USP, 20 mg. | Do. |
| ANDA 80-785 | Tripelennamine HCl Tablets USP, 50 mg. | Do. |
| ANDA 80-853 | Betalin-S (thiamine HCl injection USP), 100 mg/mL. | Eli Lilly and Co. |
| ANDA 83-209 | Estratab Tablets (esterified estrogens tablets USP) 0.625 mg. | Solvay Pharmaceuticals, Inc. |
| ANDA 83-488 | Estrogenic Substance (sterile estrone suspension USP) for Injection. | Wyeth Pharmaceuticals. |
| ANDA 83-607 | Hydrochlorothiazide Tablets USP. | Impax Laboratories, Inc. |
| ANDA 83-720 | Probenecid and Colchicine Tablets USP, 500 mg/0.5 mg. | Do. |
| ANDA 83-789 | Furacin (nitrofurazone) Topical Cream. | Shire Pharmaceutical Development, Inc. |
| ANDA 83-967 | Trichlormethiazide Tablets USP, 4 mg. | Impax Laboratories, Inc. |
| ANDA 84-029 | Hydrochlorothiazide Tablets USP, 25 mg. | Do. |
| ANDA 84-444 | Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP), No. 2 Capsules, 325 mg/15 mg. | A.H. Robins Co. |
| ANDA 84-541 | Propantheline Bromide Tablets USP, 15 mg. | Impax Laboratories, Inc. |
| ANDA 85-057 | Tylenol With Codeine (acetaminophen and codeine phosphate oral solution USP) Elixir, 120 mg/12 mg. | Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Pharmaceutical Research and Development, L.L.C., 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602. |
| ANDA 85-856 | Phenaphen-650 With Codeine (acetaminophen and codeine phosphate tablets USP) Tablets, 650 mg/30 mg. | A.H. Robbins Co. |
| ANDA 86-405 | Sorbitrate (isosorbide dinitrate tablets USP), 20 mg. | AstraZeneca Pharmaceuticals LP. |
| ANDA 86-530 | Seconal (secobarbital sodium) Suppositories. | Eli Lilly and Co. |
| ANDA 86-683 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg. | Purpac Pharmaceutical Co. |
| ANDA 86-715 | Estratab Tablets (esterified estrogens tablets USP), 0.3 mg. | Solvay Pharmaceuticals. |
| ANDA 87-158 | Fluonid (fluocinolone acetonide) Solution, 0.01%. | Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, GA 92623-9534. |
| ANDA 87-847 | Atropine and Demerol (atropine sulfate and meperidine HCl) Injection, 0.4 mg/75 mg/mL. | Abbott Laboratories. |
| ANDA 87-848 | Atropine and Demerol (atropine sulfate and meperidine HCl) Injection, 0.4 mg/100 mg/mL. | Do. |
| ANDA 87-853 | Atropine and Demerol (atropine sulfate and meperidine HCl) Injection, 0.4 mg/50 mg/mL. | Do. |
| ANDA 87-864 | Triple Sulfa Vaginal Cream (sulfathiazole, sulfacetamide, and sufabenzamide). | Alpharma. |
| ANDA 88-125 | Sorbitrate (isosorbide dinitrate tablets USP), 40 mg. | AstraZeneca Pharmaceuticals, LP. |
| ANDA 88-343 | Bromanyl (bromodiphenhydramine HCl and codeine phosphate) Cough Syrup, 12.5 mg/5 mL and 10 mg/5 mL). | Alpharma. |
| ANDA 89-561 | Chlorpropamide Tablets USP, 100 mg. | Lederle Laboratories. |
| ANDA 89-562 | Chlorpropamide Tablets USP, 250 mg. | Do. |
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 (21 CFR 5.82), approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective September 17, 2003
Dated: July 18, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-20949 Filed 8-15-03; 8:45 am]
BILLING CODE 4160-01-S