Notices. Notice
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/register/2004/05/05/04-10194·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0159] Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is withdrawing approval of 92 new drug applications
(NDAs)and 49 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: June 4, 2004 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 5-292 Estinyl (ethinyl estradiol) Tablets Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 NDA 5-795 Furacin (nitrofurazone) Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850 NDA 6-110 Dienestrol (dienestrol) Cream Ortho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Research & Development, L.L.C., 920 Highway 202, P.O. Box 300, Raritan, NJ 08869#ndash;0602 NDA 6-800 Paradione (paramethadione) Abbott Laboratories, D-491/AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157 NDA 7-110 Cortone Acetate (cortisone acetate injectable suspension USP) Injectable Suspension Merck & Co., Inc., Sumneytown Pike, BLA-20, P.O. Box 4, West Point, PA 19486 NDA 7-707 Phenurone (phenacemide) Tablets Abbott Laboratories NDA 7-750 Cortone Acetate (cortisone acetate tablet USP) Tablets Merck & Co., Inc. NDA 8-328 Spectrocin Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000 NDA 8-604 Phenergan VC Syrup (promethazine hydrochloride
(HCl)and phenylephrine HCl) and Phenergan Expectorant (promethazine HCl, ipecac, and potassium guaiacolsulfonate) Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 8-857 Phenergan Injection (promethazine HCl) Do. NDA 9-298 Amm-I-Dent (sodium lauroyl sarcosinate/urea/ammonium phosphate) Toothpaste and Tooth Powder Block Drug Co., Inc., 257 Cornelison Ave., Jersey City, NJ 07302 NDA 10-039 Avlosulfon (dapsone) Tablets Wyeth Pharmaceuticals NDA 10-727 Peri-Colace Capsules (30 milligrams
(mg)casanthranol/100 mg docusate sodium) and Syrup (30 mg casanthranol/60 mg docusate sodium per 15 milliliters (mL)) Shire Pharmaceutical Development, Inc. NDA 10-775 Trilafon (perphenazine) Tablets Schering Corp. NDA 10-858 Enzactin (triacetin) Cream Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940-0871 NDA 10-971 PMB (conjugated estrogens USP with meprobamate) Tablets Wyeth Pharmaceuticals NDA 11-140 Enzactin (triacetin) Powder Wyeth Consumer Healthcare NDA 11-460 Lanesta (chlorindanol) Vaginal Gel Sanofi-Synphelabo, Inc., 90 Park Ave., New York, NY 10016 NDA 11-860 Humorsol (demecarium bromide) Ophthalmic Solution Merck & Co., Inc. NDA 11-977 Decadron Ophthalmic Ointment (dexamethasone sodium phosphate ophthalmic ointment) Do. NDA 12-052 Hydrocortone (hydrocortisone sodium phosphate injection USP) Injection, 50 mg/mL Do. NDA 12-071 Decadron (dexamethasone sodium phosphate injection USP) Injection, 4 mg/mL and 24 mg/mL Do. NDA 12-095 Orinase (sterile tolbutamide sodium) Diagnostic Sterile Powder for Injection Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199 NDA 12-283 Hygroton (chlorthalidone) Tablets, 25 mg, 50 mg, and 100 mg Aventis Pharmaceuticals, Inc., Mail Stop BX2 - 209G, 200 Crossing Blvd., Bridgewater, NJ 08807-0890 NDA 12-359 Salutensin and Salutensin-DEMI (hydroflumethiazide and reserpine) Tablets Shire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850 NDA 12-376 Decadron (dexamethasone) Elixir, 0.5 mg/5 mL Merck & Co. Inc. NDA 12-594 Metahydrin (trichlormethiazide) Tablets, 2 mg and 4 mg Aventis Pharmaceuticals, Inc. NDA 12-657 Celestone (betamethasone tablets USP) Tablets Schering Corp. NDA 12-972 Metatensin (trichlormethiazide and reserpine) Tablets, 2 mg/0.1 mg and 4 mg/0.1 mg Aventis Pharmaceuticals, Inc. NDA 14-116 Johnson #Johnson First Aid Spray (dequainium acetate and cetylpyridinium chloride) Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Sillman, NJ 08558 NDA 14-122 Protopam (pralidoxime chloride) Tablets Wyeth Pharmaceuticals NDA 14-127 Xylocaine (lidocaine) 5% Solution AstraZeneca LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355 NDA 14-713 Etrafon (perphenazine and amitriptyline HCl) and Etrafon Forte Tablets Schering Corp. NDA 15-103 Regroton (chlorthalidone, 50 mg and reserpine, 0.25 mg) and Demi-Regroton (chlorthalidone, 25 mg and reserpine, 0.125 mg) Tablets Aventis Pharmaceuticals, Inc. NDA 16-034 Vontrol (diphenidol HCl) Injection GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 NDA 16-035 Vontrol (diphenidol pamoate) Suspension Do. NDA 16-036 Vontrol (diphenidol) Suppositories Do. NDA 16-087 Valium (diazepam) Injection Roche Laboratories, Inc., 340 Kingsland St., Nutley, NJ 07110-1199 NDA 16-110 Prolixin (fluphenazine enanthate) Injection, 25 mg/mL Apothecon, c/o Bristol-Myers Co., P.O. Box 4500, Princeton, NJ 08543-4500 NDA 16-618 Pondimin (fenfluramine HCl) Tablets and Ponderex (fenfluramine HCl) Capsules A.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 16-647 Quinaglute (quinidine gluconate) Dura-Tabs Berlex Laboratories, Inc., 340 Changebridge Rd., P.O. Box 1000, Montville, NJ 07045-1000 NDA 16-786 Ovral 28 (norgestrel/ethinyl estradiol) and Ferrous Fumarate Tablets Wyeth Pharmaceuticals NDA 16-803 Bronkaid (epinephrine inhalation aerosol) Mist Bayer Consumer Care Division, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962-1910 NDA 16-849 Selsun Blue Shampoo Ross Laboratories, 625 Cleveland Ave., Columbus, OH 43215-1754 NDA 16-883 Antiminth (pyrantel pamoate) Oral Suspension Pfizer Consumer Healthcare, 201 Tabor Rd., Morris Plains, NJ 07950 NDA 16-912 Larodopa (levadopa) Tablets and Capsules Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199 NDA 16-985 Gleem (sodium fluoride) Dentrifice Proctor & Gamble Pharmaceuticals, Inc., Oral Care Products Division, 8700 Mason-Montgomery Rd., Mason, OH 45040 NDA 17-020 Panwarfin (warfarin sodium tablets USP) Tablets, 2 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, and 25 mg Abbott Laboratories NDA 17-389 Dial 2 (pyrithione zinc) Dandruff Shampoo Armour-Dial, Inc., 15101 N. Scottsdale Rd., Scottsdale, AZ 85260 NDA 17-535 Lorelco (probucol) Tablets Aventis Pharmaceuticals, Inc. NDA 17-536 Diprosone (betamethasone dipropionate) Cream, 0.05% Schering Corp. NDA 17-684 Pyrolite (technetium Tc-99m pyro- and trimeta-phosphates kit) CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730 NDA 17-710 Nalfon (fenoprofen calcium) Tablets Dista Products Ltd., c/o Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 NDA 17-736 Paxipam (halazepam) Tablets, 20 mg and 40 mg Schering Corp. NDA 17-853 Proventil (albuterol sulfate) Tablets, 2 mg and 4 mg Do. NDA 17-895 Janimine (imipramine HCl) Tablets Abbott Laboratories NDA 17-952 Trimpex (trimethoprim) Tablets Hoffman-La Roche, Inc. NDA 18-306 NasalCrom (cromolyn sodium) Nasal Solution Pharmacia Consumer Healthcare, 100 Route 206 North, Peapack, NJ 07977 NDA 18-521 Vancenase (beclomethasone dipropionate) Nasal Inhaler Schering Corp. NDA 18-584 Beconase (beclomethasone dipropionate) Inhalation Aerosol GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709 NDA 18-587 Wytensin (guanabenz acetate) Tablets, 4 mg, 8 mg, and 16 mg Wyeth Pharmaceuticals NDA 18-592 Monistat 5 (miconazole nitrate) Tampons, 100 mg Personal Products Co., 199 Grandview Rd., Skillman, NJ 08558 NDA 19-059 Inderide LA (propranolol HCl and hydrochlorothiazide) Capsules, 80 mg/50 mg, 120 mg/50 mg, and 160 mg/50 mg Ayerst Pharmaceuticals, c/o Wyeth Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 19-279 Dimetane DX (brompheniramine maleate/ pseudoephedrine HCl/dextromethorphan HBr) Cough Syrup A.H. Robins Co., c/o Wyeth Pharmaceuticals NDA 19-428 Pseudoephedrine HCl and Chlorpheniramine Maleate Extended-Release Capsules Central Pharmaceuticals, c/o Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201 NDA 19-757 Chibroxin (norfloxacin) Sterile Ophthalmic Solution, 0.3% Merck &Co., Inc. NDA 19-858 Cipro (ciprofloxacin) in Sodium Chloride Bayer Corp. NDA 20-055 Glyburide (micronized) Tablets Aventis Pharmaceuticals, Inc. NDA 20-058 Thioplex (thiotepa) For Injection) Immunex Corp., 51 University St., Seattle, WA 98101-2936 NDA 20-135 Motrin (ibuprofen) Chewable Tablets McNeil Consumer & Specialty Pharmaceuticals, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299 NDA 20-233 Rhinocort (budesomide) Nasal Inhaler AstraZeneca LP NDA 20-240 Renormax (spirapril HCl) Tablets, 3 mg, 6 mg, 12 mg, and 24 mg Schering Corp. NDA 20-418 Motrin (ibuprofen) Caplets McNeil Consumer & Specialty Pharmaceuticals NDA 20-469 Vancenase AQ (beclomethasone dipropionate monohydrate) Nasal Spray Schering Corp. NDA 20-476 Motrin (ibuprofen) Oral Drops McNeil Consumer &Specialty Pharmaceuticals NDA 20-874 Lunelle (estradiol cypionate and medroxyprogesterone acetate) Injection Pharmacia Corp., c/o Pfizer Pharmaceuticals Group, 235 E. 42d St., New York, NY 10017-5755 NDA 20-951 Tagamet HB (cimetidine) Suspension GlaxoSmithKline Consumer Healthcare LP, 1500 Littleton Rd., Parsippany, NJ 07054-3884 NDA 50-012 Garamycin (gentamicin sulfate injection USP) Injectable Schering Corp. NDA 50-051 Grisactin (griseofulvin, microcrystalline) Capsules Wyeth Pharmaceuticals NDA 50-092 Pathocil (dicloxacillin sodium) for Suspension Do. NDA 50-094 Erythrocin (erythromycin) Suppositories Abbott Laboratories NDA 50-111 Unipen (nafcillin sodium) Capsules Wyeth Pharmaceuticals NDA 50-262 Declomycin (demeclocycline HCl) Capsules Lederle Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 50-273 Achromycin (tetracycline HCl) Intravenous Injection Do. NDA 50-276 Achromycin (tetracyclilne HCl and procaine HCl) Sterile Intramuscular Injection Do. NDA 50-296 Erythrocin Suspension Abbott Laboratories NDA 50-324 Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Ophthalmic Ointment Merck Research Laboratories, Sumneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486-0004 NDA 50-341 Fungizone (amphotericin B) Oral Suspension Bristol-Myers Squibb Co. NDA 50-425 Garamycin (gentamicin sulfate) Ophthalmic Ointment Schering Corp. NDA 50-439 Erythrocin (erythromycin stearate) Abbott Laboratories NDA 50-482 Keflin (cephalothin sodium) for Injection Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 NDA 50-744 Periostat (doxycycline hyclate USP) Capsules, 20 mg CollaGenex Pharmaceuticals, Inc., 301 South State St., Newtown, PA 18940 ANDA 60-006 Pen-Vee K (penicillin V potassium) Tablets, 125 mg, 250 mg, and 500 mg
(base)Wyeth Pharmaceuticals ANDA 60-611 Neomycin Sulfate and Methylprednisolone Acetate Topical Cream Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001 ANDA 60-624 Omnipen (ampicillin) Capsules, 250 mg and 500 mg Wyeth Pharmaceuticals ANDA 62-178 Grisactin Ultra (griseofulvin, ultramicro crystalline) Tablets, 125 mg and 250 mg Do. ANDA 62-438 Grisactin Ultra (griseofulvin, ultramicro crystalline) Tablets, 165 mg and 330 mg Do. ANDA 62-549 Keflin (cephalothin sodium for injection USP), 1 g and 2 g Lilly Research Laboratories ANDA 62-690 Ticar (ticarcillin disodium) Injection, 3 g GlaxoSmithKline ANDA 62-905 Clindamycin Phosphate Injection USP, 150 mg/mL Loch Pharmaceuticals, c/o Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146 ANDA 63-087 Lincomycin HCl USP Abbott Laboratories ANDA 63-321 Vancoled (vancomycin HCl for oral solution USP) Lederle Laboratories, c/o Wyeth Pharmaceuticals ANDA 70-188 Naloxone HCl Injection USP, 0.02 mg/mL Wyeth Pharmaceuticals ANDA 70-189 Naloxone HCl Injection USP, 0.02 mg/mL Do. ANDA 70-190 Naloxone HCl Injection USP, 0.4 mg/mL Do. ANDA 70-191 Naloxone HCl Injection USP, 0.4 mg/mL Do. ANDA 70-480 Leucovorin Calcium for Injection, 50 mg Elkins Sinn, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 ANDA 70-917 Nalbuphine HCl Injection, 20 mg/mL Abbott Laboratories ANDA 72-639 Metoclopramide HCl Tablets USP, 10 mg Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 ANDA 74-051 Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 ANDA 74-211 Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216 ANDA 74-257 Naproxen Sodium Tablets USP Do. ANDA 80-454 Meperidine HCl Tablets USP, 50 mg Do. ANDA 80-553 Thiamine HCl Injection USP, 100 mg/mL Do. ANDA 80-554 Cyanocobalamin Injection USP Do. ANDA 80-577 Diphenhydramine HCl Injection USP, 50 mg/mL Do. ANDA 81-224 Leucovorin Calcium for Injection, 100 mg Elkins Sinn, c/o Wyeth Pharmaceuticals ANDA 81-239 Cycrin (medroxyprogesterone acetate) Tablets USP, 2.5 mg Do. ANDA 81-240 Cycrin (medroxyprogesterone) Tablets USP, 5 mg Do. ANDA 83-159 Calcium Gluceptate Injection Abbott Laboratories ANDA 83-262 Secobarbital Sodium Injection USP, 50 mg/mL Wyeth Pharmaceuticals ANDA 83-640 Quinidine Sulfate Tablets USP, 200 mg Roxane Laboratories, Inc. ANDA 84-316 Dimenhydrinate Injection USP, 50 mg Wyeth Pharmaceuticals ANDA 84-386 Digoxin Injection USP, 500 micrograms/2 mL Do. ANDA 84-445 Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP) No. 3 Capsules A. H. Robins Co. ANDA 84-446 Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP) No. 4 Capsules Do. ANDA 85-328 Theo-Dur (theophylline) Extended-Release Tablets, 100 mg and 300 mg Schering Corp. ANDA 85-632 Quinidine Sulfate Tablets USP, 300 mg Roxane Laboratories, Inc. ANDA 86-134 Nitro-Bid Ointment (nitroglycerin ointment USP, 2%) Altana Inc., 60 Baylis Rd., Melville, NY 11747 ANDA 86-348 Prochlorperazine Edisylate Injection USP, 5 mg (base)/mL Wyeth Pharmaceuticals ANDA 86-998 Theo-Dur (theophylline) Extended-Release Tablets, 200 mg Schering Corp. ANDA 88-584 DHCplus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules, 356.4 mg Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431 ANDA 89-116 Brompheril (dexbrompheniramine maleate/ pseudoephedrine sulfate) Extended-Release Tablets, 6 mg/120 mg Copley Pharmaceuticals, Inc., c/o Teva Pharmaceuticals, 1090 Horsham Rd., North Wales, PA 19454 ANDA 89-131 Theo-Dur (theophylline) Extended-Release Tablets, 450 mg Schering Corp. ANDA 89-386 Cycrin (medroxyprogesterone acetate) Tablets, 10 mg Wyeth Pharmaceuticals ANDA 89-573 Methylprednisolone Sodium Succinate for Injection USP, 40 mg Abbott Laboratories ANDA 89-574 Methylprednisolone Sodium Succinate for Injection USP, 125 mg Do. ANDA 89-575 Methylprednisolone Sodium Succinate for Injection USP, 500 mg Do. ANDA 89-576 Methylprednisolone Sodium Succinate for Injection USP, 1000 mg Do. ANDA 89-822 Uni-Dur (theophylline) Extended-Release Tablets, 400 mg Schering Corp. ANDA 89-823 Uni-Dur (theophylline) Extended-Release Tablets, 600 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 by the Commissioner, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 4, 2004. Dated: March 22, 2004. Steven K. Galson, Acting Deputy Director, Center for Drug Evaluation and Research. [FR Doc. 04-10194 Filed 5-4-04; 8:45 am]
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