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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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]
BILLING CODE 4160-01-S