Human drugs: New drug applications— Eli Lilly and Co. et al; approval withdrawn,

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Federal Register: August 18, 2003 (Volume 68, Number 159)NoticesPage 49481-49488From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr18au03-115

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 2003N-0335Eli Lilly and Co. et al.; Withdrawal of Approval of 80 New Drug Applications and 75 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

[Page 49482]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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Do. Injection.

NDA 5-970

Sotradecol (sodium Wyeth Pharmaceuticals, tetradecyl sulfate) P.O. Box 8299, Injection.

Philadelphia, PA 19101-8299.

NDA 7-898

Benemid (probenecid) Merck & Co., Inc., Tablets.

Sunneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486.

NDA 8-048

Xylocaine (lidocaine) AstraZeneca Ointment.

Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803- 8355.

NDA 8-228

Hydrocortone

Merck & Co., Inc. (hydrocortisone acetate) Acetate Injectable Suspension.

NDA 8-565

Thiosulfil

Wyeth Pharmaceuticals. (sulfamethizole) Tablets and Suspension.

NDA 9-489

Pathilon

Lederle Laboratories, (tridehixethyl)

P.O. Box 8299, Tablets.

Philadelphia, PA 19101-8299.

NDA 10-210

Metymid Ophthalmic Schering Corp., 2000 (prednisolone acetate Galloping Hill Rd., and sulfacetamide

Kenilworth, NJ 07033. sodium).

NDA 10-220

Hypaque-M 75% and 90% Amersham Health, 101 Hypague Compound

Carnegie Center, (diatrizoate meglumine Princeton, NJ 08540- and diatrizoate

6231. sodium) Injection.

NDA 10-348

Sparine (promazine Wyeth Pharmaceuticals. hydrochloride (HCl)) Tablets.

NDA 10-496

Xylocaine-MPF 5%

AstraZeneca Solution With Glucose Pharmaceuticals LP. 7.5% (lidocaine HCl and dextrose).

NDA 10-562

Hydeltra-T.B.A.

Merck & Co., Inc. (prednisolone tebutate).

NDA 10-753

Estradurin

Wyeth Pharmaceuticals. (polyestradiol phosphate) Injection.

NDA 10-942

Sparine (promazine HCl) Do. Syrup and Concentrate.

NDA 11-338

Fluothane Inhalation Do. (halothane USP).

NDA 11-418

Dimetane Ten Injectable Do. (brompheniramine maleate).

NDA 11-673

Tepanil (diethylpropion 3M Pharmaceuticals, 3M HC1) Tablets.

Center, Bldg. 270-3A- 01, St. Paul, MN 55144-1000.

NDA 11-958

Hydropres (reserpine Merck & Co., Inc. and hydrochlorothiazide).

NDA 12-383

ColBenemid (probenecid Do. and colchicine) Tablets.

NDA 12-418

Akineton (biperiden Abbott Laboratories, lactate) Injection. 200 Abbott Park Rd., Abbott Park, IL 60064- 6157.

NDA 12-489

Exna (benzthiazide) Wyeth Pharmaceuticals. Tablets.

[Page 49483]

NDA 12-731

Decaspray

Merck & Co., Inc. (dexamethasone) Topical Aerosol.

NDA 12-882

Isordil Tembids

Wyeth Pharmaceuticals. (isosorbide dinitrate) Controlled-Release Tablets and Capsules.

NDA 12-947

Artane (trihexyphenidyl Lederle Laboratories. HCl) Sustained-Release Capsules.

NDA 13-264

Hydromox (quinethazone) Wyeth Pharmaceuticals. Tablets.

NDA 13-334

Decadron With Xylocaine Merck & Co., Inc. Injection (dexamethasone sodium phosphate and lidocaine HCl).

NDA 13-378

Dymelor (acetohexamide) Eli Lilly and Co. Tablets.

NDA 13-731

Bilopaque (tyropanoate Amersham Health. sodium) Capsules.

NDA 14-763

Citanest Plain

AstraZeneca (prilocaine HCl) and Pharmaceuticals LP. Citanest Forte (prilocaine HCl and epinephrine) Injection.

NDA 15-052

Atabrine (quinacrine Abbott Laboratories. HCl) Injection.

NDA 15-921

Haldol (haloperidol) Ortho-McNeil Tablets.

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 Do. lactate) Oral Concentrate.

NDA 16-192

Sorbitrate (isosorbide AstraZeneca dinitrate) Oral 5

Pharmaceuticals LP. milligram (mg) and 10 mg Tablets.

NDA 16-675

Decadron LA

Merck & Co., Inc. (dexamethasone acetate) Sterile Suspension.

NDA 16-776

Sorbitrate (isosorbide AstraZeneca dinitrate) Chewable Pharmaceuticals LP. Tablets.

NDA 17-048

Peptavlon

Wyeth Pharmaceuticals. (pentagastrin) for Subcutaneous Injection.

NDA 17-406

Dicopac Kit.

Amersham Health.

NDA 17-503

Combipres (clonidine Boehringer Ingelheim HCl and

Pharmaceuticals, chlorthalidone)

Inc., 900 Ridgebury Tablets.

Rd., P.O. Box 368, Ridgefield, CT 06877- 0368.

NDA 17-638

Thypinone (protirelin) Abbott Laboratories. Injection.

NDA 17-653

Technetium Tc-99m

Amersham Health. HEDSPA Multidose Kit.

NDA 17-691

Diprosone

Schering Corp. (betamethasone dipropionate) Ointment, 0.05%.

NDA 17-751

Duranest (etidocaine AstraZeneca HCl) Injection.

Pharmaceuticals LP.

NDA 17-775

Technetium Tc-99m HSA Medi-Physics, Inc., Kit.

d.b.a., Nycomed Amersham Imaging, 101 Carnegie Center, Princeton, NJ 08540- 6231.

NDA 17-784

Technetium Tc-99m TSC Amersham Health. Kit.

NDA 17-980

Mazanor (mazindol) Wyeth Pharmaceuticals. Tablets.

NDA 17-982

Amipaque (metrizamide) Amersham Health. Injection.

NDA 17-992

Crescormon (somatropin, Genentech, Inc., 1 DNA pituitary).

Way, MS[numsign]48, South San Francisco, CA 94080-4990.

NDA 18-021

Asendin (amoxapine) 25 Wyeth Pharmaceuticals. mg, 50 mg, 100 mg, and 150 mg Tablets.

[Page 49484]

NDA 18-153

Beclovent

GlaxoSmithKline, Five (beclomethasone

Moore Dr., Research dipropionate)

Triangle Park, NC Inhalation Aerosol. 27709.

NDA 18-280

Yutopar (ritodrine HCl) Solvay Tablets and Injection. Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.

NDA 18-290

Secretin-Ferring Powder Ferring for Injection.

Pharmaceuticals, Inc., 120 White Plains Rd., Suite 400, Tarrytown, NY 10591.

NDA 18-381

Regular Purified Pork Novo Nordisk Insulin.

Pharmaceuticals, Inc., 100 College Rd. West, Princeton, NJ 08540.

NDA 18-383

Lente Purified Pork Do. Insulin Zinc Supension.

NDA 18-450

Nitropress (sodium Abbott Laboratories. nitroprusside) Injection.

NDA 18-623

NPH Purified Pork

Novo Nordisk Isophane Insulin

Pharmaceuticals, Inc. Suspension.

NDA 19-112

Ventolin (albuterol GlaxoSmithKline. sulfate) Tablets.

NDA 19-269

Ventolin (albuterol Do. sulfate) Inhalation Solution, 0.5%.

NDA 19-280

Cyklokapron (tranexamic Pharmacia & Upjohn acid) Tablets.

Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199.

NDA 19-489

Ventolin (albuterol GlaxoSmithKline. sulfate) Rotacaps Inhalation Powder.

NDA 19-536

Inderal (propranolol Wyeth Pharmaceuticals. HCl) Oral Suspension.

NDA 19-773

Ventolin (albuterol GlaxoSmithKline. sulfate) Nebules Inhalation Solution, 0.083%.

NDA 19-836

Supprelin (histrelin Shire Pharmaceutical acetate) Injection. Development, Inc., 1801 Research Blvd., Suite 600, Rockville, MD 20850.

NDA 20-063

Technetium Tc-99m Red Cadema Corp., c/o Blood Cell Kit.

Number One Corporation, 50 Washington St., Norwalk, CT 06854.

NDA 20-924

Cernevit-12

Baxter Healthcare Multivitamins.

Corp., Route 120 and Wilson Rd., RLT-10, Round Lake, IL 60073- 0490.

NDA 21-384

Duranest (etidocaine Dentsply HCl and epinephrine Pharmaceutical, 3427 bitartrate) Injection. Concord Rd., York, PA 17402.

NDA 50-202

Chloromycetin

Parkdale Hydrocortisone

Pharmaceuticals, Ophthalmic

Inc., 501 Fifth St., (chloramphenicol and Bristol, TN 37620. hydrocortisone acetate for ophthalmic suspension USP).

NDA 50-251

Aureomycin

Wyeth Pharmaceuticals. (chlortetracycline HCl) Capsules.

NDA 50-257

Declomycin

Do. (demeclocycline HCl) Syrup Drops.

NDA 50-263

Achromycin V

Do. (tetracycline HCl) Suspension and Drops.

NDA 50-264

Achromycin

Do. (tetracycline HCl).

NDA 50-315

Minocin (minocycline Do. HCl) Capsules.

NDA 50-451

Minocin (minocycline Do. HCl) Tablets.

NDA 50-483

Nebcin (tobramycin Eli Lilly and Co. sulfate) Sensitivity Disk.

NDA 50-484

Cerubidine

Wyeth Pharmaceuticals. (daunorubicin HCl) Injection.

NDA 50-493

Topicycline

Shire Pharmaceutical (tetracycline HCl) Development, Inc. Solution.

[Page 49485]

NDA 50-508

Cyclapen-W

Wyeth Pharmaceuticals. (cyclacillin) Oral Suspension.

NDA 50-509

Cyclapen-W

Do. (cyclacillin) Tablets.

NDA 50-544

Netromycin (netilmicin Schering Corp. sulfate) Injection.

NDA 50-633

Cefpiramide Sodium Wyeth Pharmaceuticals. Injection.

ANDA 60-007

Pen-Vee K for Oral Do. Solution (penicillin V potassium for oral solution), 125 mg (base)/5 milliliters (mL) and 250 mg (base)/ 5 mL.

ANDA 60-462

Garamycin (gentamicin Schering Corp. sulfate) Cream, 0.1%.

ANDA 61-151

Nilstat (nystatin) Lederle Laboratories. tablets USP) Oral Tablets, 500,000 units.

ANDA 61-325

Nilstat (nystatin) Do. Vaginal Tablets, 100,000 units.

ANDA 61-444

Nilstat (nystatin) Do. Ointment, 100,000 units/gram (g).

ANDA 61-445

Nilstat (nystatin) Do. Cream, 100,000/g.

ANDA 61-633

Robimycin

A.H. Robins Co., P.O. (erythromycin)

Box 8299, Robitabs, 250 mg.

Philadelphia, PA 19101-8299.

ANDA 61-734

Robitet (tetracycline Wyeth Pharmaceuticals. HCl capsules USP) Robicaps, 250 mg and 500 mg.

ANDA 62-120

Wymox (amoxicillin) Do. Capsules, 250 mg and 500 mg.

ANDA 62-302

Otobiotic (polymyxin B Schering Corp. sulfate and hydrocortisone otic solution USP) Sterile Otic Solution.

ANDA 62-579

Precef (ceforanide) for Apothecon, c/o Bristol- Injection.

Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543- 4500.

ANDA 62-821

Cephalexin Capsules TEVA Pharmaceutical USP, 250 mg.

USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.

ANDA 62-823

Cephalexin Capsules TEVA Pharmaceutical USP, 500 mg.

USA.

ANDA 62-860

Ampicillin for

Apothecon. Injection.

ANDA 62-867

Cephalexin for Oral TEVA Pharmaceutical Suspension USP, 250 mg/ USA. 5mL.

ANDA 62-873

Cephalexin for Oral Do. Suspension USP, 125 mg/ 5mL.

ANDA 62-961

Cefadyl (cephapirin) Apothecon. for Injection.

ANDA 63-120

Tobramycin Sulfate AstraZeneca LP. Injection USP, 2 mL vial, 40 mg/mL.

ANDA 63-122

Tobramycin Sulfate Do. Injection USP, 40 mg/ mL.

ANDA 64-131

Trimox (amoxicillin Apothecon. tablets USP), Tablets, 125 mg and 250 mg.

ANDA 70-128

Propranolol HCl Tablets ESI Lederle, c/o USP, 80 mg.

Lederle Laboratories, 401 North Middletown Rd., Pearl River, NY 10965-1299.

ANDA 70-318

Haloperidol Oral

Alpharma, U.S. Solution USP

Pharmaceuticals (Concentrate), 2 mg/ Division, 200 Elmora mL.

Ave., Elizabeth, NJ 07207.

ANDA 70-757

Propranolol HCl Tablets Purepac Pharmaceutical USP, 80 mg.

Co., 200 Elmora Ave., Elizabeth, NJ 07207.

[Page 49486]

ANDA 70-814

Propranolol HCl Tablets Do. USP, 10 mg.

ANDA 70-815

Propranolol HCl Tablets Do. USP, 20 mg.

ANDA 70-816

Propranolol HCl Tablets Do. USP, 40 mg.

ANDA 70-817

Propranolol HCl Tablets Do. USP, 60 mg.

ANDA 71-495

Propranolol HCl Tablets ESI Lederle. USP, 60 mg.

ANDA 71-496

Propranolol HCl Tablets Do. USP, 90 mg.

ANDA 71-673

Doxepin HCl Capsules Do. USP, 50 mg.

ANDA 71-674

Doxepin HCl Capsules Do. USP, 75 mg.

ANDA 71-675

Doxepin HCl Capsules Do. USP, 100 mg.

ANDA 71-676

Doxepin HCl Capsules Do. USP, 150 mg.

ANDA 71-685

Doxepin HCl Capsules Do. USP, 10 mg.

ANDA 71-686

Doxepin HCl Capsules Do. USP, 25 mg.

ANDA 72-026

Fentanyl Citrate and AstraZeneca LP. Droperidol Injection.

ANDA 72-687

Foamicon (alumina and Novartis Consumer magnesium trisilicate Health, Inc., 200 tablets USP), 80 mg Kimball Dr., and 20 mg.

Parsippany, NJ 07054- 0622.

ANDA 73-080

Loperamide HCl Capsules Roxane Laboratoires, USP, 2mg.

Inc., P.O. Box 16532, Columbis, OH 43216.

ANDA 73-403

Questran

Bristol-Myers Squibb (cholestyramine)

Co. Tablets, 800 mg and 1,000 mg.

ANDA 73-440

Desoximetasone Ointment Altana, Inc., 60 USP, 0.25%.

Baylis Rd., Melville, NY 11747.

ANDA 73-494

Thiothixene HCl

Roxane Laboratories, Intensol Oral Solution Inc. (Concentrate), 5 mg/ mL.

ANDA 74-036

Piroxicam Capsules USP, SCS Pharmaceuticals, 10 mg and 20 mg.

Box 5110, Chicago, IL 60680-9889.

ANDA 74-734

Iopamidol Injection Faulding USP, 61% and 76%.

Pharmaceuticals, Mack- Cali Centre 11, 650 From Rd., Paramus, NJ 07652.

ANDA 75-100

Bromocriptine Mesylate Lek, Pharmaceutical Capsules USP, 5 mg. 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 Apothecon. USP, 100 mg, 200 mg, and 300 mg.

ANDA 80-081

Sulfadiazine Tablets Impax Laboratories, USP, 500 mg.

Inc., 30831 Huntwood Ave., Hayward, CA 94544.

ANDA 80-254

Testosterone Propionate Eli Lilly and Co. Injection USP, 50 mg/ mL.

ANDA 80-686

Folic Acid Tablets USP, Impax Laboratories, 1 mg.

Inc.

ANDA 80-781

Hydrocortisone Tablets Do. USP, 20 mg.

ANDA 80-785

Tripelennamine HCl Do. Tablets USP, 50 mg.

ANDA 80-853

Betalin-S (thiamine HCl Eli Lilly and Co. injection USP), 100 mg/ mL.

ANDA 83-209

Estratab Tablets

Solvay (esterified estrogens Pharmaceuticals, Inc. tablets USP) 0.625 mg.

ANDA 83-488

Estrogenic Substance Wyeth Pharmaceuticals. (sterile estrone suspension USP) for Injection.

[Page 49487]

ANDA 83-607

Hydrochlorothiazide Impax Laboratories, Tablets USP.

Inc.

ANDA 83-720

Probenecid and

Do. Colchicine Tablets USP, 500 mg/0.5 mg.

ANDA 83-789

Furacin (nitrofurazone) Shire Pharmaceutical Topical Cream.

Development, Inc.

ANDA 83-967

Trichlormethiazide Impax Laboratories, Tablets USP, 4 mg. Inc.

ANDA 84-029

Hydrochlorothiazide Do. Tablets USP, 25 mg.

ANDA 84-444

Phenaphen with Codeine A.H. Robins Co. (acetaminophen and codeine phosphate capsules USP), No. 2 Capsules, 325 mg/15 mg.

ANDA 84-541

Propantheline Bromide Impax Laboratories, Tablets USP, 15 mg. Inc.

ANDA 85-057

Tylenol With Codeine Ortho-McNeil (acetaminophen and Pharmaceuticals, codeine phosphate oral Inc., c/o Johnson & solution USP) Elixir, Johnson 120 mg/12 mg.

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 A.H. Robbins Co. Codeine (acetaminophen and codeine phosphate tablets USP) Tablets, 650 mg/30 mg.

ANDA 86-405

Sorbitrate (isosorbide AstraZeneca dinitrate tablets

Pharmaceuticals LP. USP), 20 mg.

ANDA 86-530

Seconal (secobarbital Eli Lilly and Co. sodium) Suppositories.

ANDA 86-683

Acetaminophen and

Purpac Pharmaceutical Codeine Phosphate

Co. Tablets USP, 300 mg/60 mg.

ANDA 86-715

Estratab Tablets

Solvay (esterified estrogens Pharmaceuticals. tablets USP), 0.3 mg.

ANDA 87-158

Fluonid (fluocinolone Allergan, 2525 Dupont acetonide) Solution, Dr., P.O. Box 19534, 0.01%.

Irvine, GA 92623- 9534.

ANDA 87-847

Atropine and Demerol Abbott Laboratories. (atropine sulfate and meperidine HCl) Injection, 0.4 mg/75 mg/mL.

ANDA 87-848

Atropine and Demerol Do. (atropine sulfate and meperidine HCl) Injection, 0.4 mg/100 mg/mL.

ANDA 87-853

Atropine and Demerol Do. (atropine sulfate and meperidine HCl) Injection, 0.4 mg/50 mg/mL.

ANDA 87-864

Triple Sulfa Vaginal Alpharma. Cream (sulfathiazole, sulfacetamide, and sufabenzamide).

ANDA 88-125

Sorbitrate (isosorbide AstraZeneca dinitrate tablets

Pharmaceuticals, LP. USP), 40 mg.

ANDA 88-343

Bromanyl

Alpharma. (bromodiphenhydramine HCl and codeine phosphate) Cough Syrup, 12.5 mg/5 mL and 10 mg/5 mL).

ANDA 89-561

Chlorpropamide Tablets Lederle Laboratories. USP, 100 mg.

ANDA 89-562

Chlorpropamide Tablets Do. USP, 250 mg.

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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 amBILLING CODE 4160-01-S

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