71 FR 116 pgs. 34940-34944 - Merck Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications
Type: NOTICEVolume: 71Number: 116Pages: 34940 - 34944
Docket number: [Docket No. 2006N-0222]
FR document: [FR Doc. E6-9440 Filed 6-15-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0222]
Merck Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 65 new drug applications (NDAs) and 52 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Effective June 16, 2006.
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 1-645 | Vitamin B6 (pyridoxine hydrochloride (HCl)) | Merck Co., Inc., 770 Sumneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486-0004 |
| NDA 5-521 | Heparin Sodium Injection USP | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 |
| NDA 5-657 | Tubocurarine Chloride Injection USP | Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 |
| NDA 5-794 | Sultrin Triple Sulfa Cream and Triple Sulfa Tablets | Ortho-McNeil Pharmaceutical, Inc., 1000 U.S. Highway 202, P.O. Box 300, Raritan, NJ 08869-0602 |
| NDA 6-012 | Folvron (folic acid and iron) | Lederle Laboratories, 401 North Middleton Rd., Pearl River, NY 10965 |
| NDA 7-149 | Rubramin (cyanocobalamin) Tablets and Capsules | Bristol-Myers Squibb Co. |
| NDA 7-504 | Acthar (corticotropin for injection) | Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., BX 2-309E, Bridgewater, NJ 08807 |
| NDA 7-794 | Neothylline (dyphylline) | Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 |
| NDA 9-176 | Cortril (hydrocortisone) Topical Ointment | Pfizer Global Pharmaceuticals, 235 East 42nd St., New York, NY 10017 |
| NDA 10-028 | Equanil (meprobamate) Tablets | Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 10-093 | Biphetamine (dextroamphetamine and amphetamine) Capsules | Celltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box 31710, Rochester, NY 14603 |
| NDA 10-513 | Ketonil (amino acids and electrolytes) | Merck Co., Inc. |
| NDA 10-787 | Iron Dextran Injection | Aventis Pharmaceuticals, Inc. |
| NDA 10-799 | Dimetane (brompheniramine maleate) Tablets and Extendtabs | Wyeth Consumer Healthcare, 5 Giralda Farms, Madison, NJ 07940 |
| NDA 11-340 | Cerumenex (triethanolamine polypeptide oleate-condensate), 10% | The Purdue Frederick Co., 1 Stamford Forum, Stamford, CT 06901-3431 |
| NDA 11-960 | Aristocort (triamcinolone diacetate) Syrup | Astellas Pharma US, Inc., 3 Parkway North, Deerfield, IL 60015-2548 |
| NDA 11-984 | Decadron Phosphate (dexamethasone sodium phosphate) Sterile Ophthalmic Solution | Merck Co., Inc. |
| NDA 12-122 | Glucagon (glucagon HCl) for Injection | Eli Lilly Co. |
| NDA 12-281 | Robaxisal (methocarbamol USP and aspirin USP) Tablets | A.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 12-649 | Periactin (cyproheptadine HCl) | Merck Co., Inc. |
| NDA 12-703 | Elavil (amitriptyline HCl) Tablets | AstraZeneca Pharmaceuticals, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355 |
| NDA 12-704 | Elavil (amitriptyline HCl) Injection | Do. |
| NDA 13-220 | Periactin (cyproheptadine HCl) Syrup, 2 milligrams (mg)/5 milliliters (mL) | Merck Co., Inc. |
| NDA 13-400 | Aldomet (methyldopa) Tablets | Do. |
| NDA 13-401 | Aldomet (methyldopate HCl) Injection, 50 mg/mL | Do. |
| NDA 13-413 | Dexacort Phosphate (dexamethasone sodium phosphate) in Respihaler | Celltech Pharmaceuticals, Inc. |
| NDA 16-016 | Aldoclor-150 and -250 (methyldopa and chlorothiazide) Tablets, 250 mg/150 mg and 250 mg/250 mg | Merck Co., Inc. |
| NDA 16-030 | Bayer 8 Hour Aspirin and Measurin Aspirin (aspirin extended-release tablets), 650 mg | Bayer Healthcare, LLC, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962-1910 |
| NDA 16-099 | Atromid-S (clofibrate) Capsules | Wyeth Pharmaceuticals |
| NDA 16-745 | Jergens Antibacterial Deodorant (triclocarban, 1%) Soap | Kao Brands Co., 2535 Springs Grove Ave., Cincinnati, OH 45214-1773 |
| NDA 16-888 | Selsun Blue (selenium sulfide) Cream/Shampoo, 1% | Abbott Laboratories, 625 Cleveland Ave., Columbus, OH 43215-1724 |
| NDA 17-569 | Renoquid (sulfacytine) Tablets | Glenwood LLC, 111 Cedar Lane, Englewood, NJ 07631 |
| NDA 17-573 | Vanceril (beclomethasone dipropionate) Inhalation Aerosol | Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 |
| NDA 17-659 | Alupent (metaproterenol sulfate) Inhalation Solution, 5% | Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 |
| NDA 17-781 | Diprosone (betamethasone dipropionate) Lotion | Schering Corp. |
| NDA 17-820 | Dobutrex (dobutamine HCl) Sterile Injection | Eli Lilly Co. |
| ANDA 18-023 | Lactated Ringer's Injection USP | B. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623-9791 |
| ANDA 18-026 | 5% Dextrose and 0.9% Sodium Chloride (NaCl) Injection | Do. |
| ANDA 18-046 | 10% Dextrose Injection USP | Do. |
| ANDA 18-047 | 10% Dextrose and 0.9% NaCl Injection USP | Do. |
| ANDA 18-184 | 0.45% NaCl Injection USP | Do. |
| ANDA 18-186 | 1/6 Molar Sodium Lactate Injection USP in Plastic Container | Do. |
| ANDA 18-197 | Ibuprofen Tablets | BASF Corp., 8800 Line Ave., Shreveport, LA 71106 |
| ANDA 18-252 | Isolyte S (multi-electrolyte injection) Injection | B. Braun Medical, Inc. |
| ANDA 18-256 | 5% Dextrose in Ringer's Injection | Do. |
| NDA 18-257 | Tonocard (tocainide HCl) Tablets, 400 mg and 600 mg | AstraZeneca Pharmaceuticals |
| ANDA 18-274 | Isolyte S (multi-electrolyte injection) with 5% Dextrose in Plastic Container | B. Braun Medical, Inc. |
| NDA 18-389 | Aldomet (methyldopa) Oral Suspension, 250 mg/5 mL | Merck Co., Inc. |
| NDA 18-682 | TZ-3 (1% tioconazole) Dermal Cream | Pfizer, Inc., 235 East 42nd St., New York, NY 10017 |
| NDA 18-686 | Normodyne (labetalol HCl USP) Injection, 5 mg/mL | Schering Corp. |
| NDA 18-687 | Normodyne (labetalol HCl USP) Tablets | Do. |
| ANDA 18-721 | Ringer's Injection USP | B. Braun Medical, Inc. |
| NDA 18-754 | Orudis (ketoprofen) Capsules, 25 mg, 50 mg, and 75 mg | Wyeth Pharmaceuticals |
| NDA 18-792 | Neopham (amino acids) Injection | Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. 2, Lake Forest, IL 60045 |
| NDA 18-901 | Aminess (essential amino acids injection with histidine) | Do. |
| NDA 18-911 | Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in NaCl Injection | Do. |
| NDA 19-083 | Theophylline and 5% Dextrose Injection | B. Braun Medical, Inc. |
| NDA 19-107 | Protropin (somatrem) for Injection | Genentech, Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990 |
| ANDA 19-138 | Alphatrex (betamethasone dipropionate cream USP) 0.05% | Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 |
| ANDA 19-143 | Alphatrex (betamethasone dipropionate ointment USP) 0.05% | Do. |
| NDA 19-383 | Proventil (albuterol sulfate extended-release tablets USP) Repetabs | Schering Corp. |
| NDA 19-401 | Pseudo-12 Suspension (pseudoephedrine polistirex extended-release suspension) | Celltech Pharmaceuticals, Inc. |
| NDA 19-523 | Cysteine HCl Injection USP, 7.25% | Hospira, Inc. |
| NDA 19-589 | Vancenase AQ (beclomethasone dipropionate) Nasal Spray | Schering Corp. |
| NDA 19-621 | Ventolin (albuterol sulfate) Syrup | GlaxoSmithKline Pharmaceuticals, 5 More Dr., P.O. Box 13358, Research Triangle Park, NC 27709 |
| NDA 20-035 | Ergamisol (levamisole HCl) Tablets | Johnson Johnson Pharmaceutical Research and Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., K1-02B, Titusville, NJ 08560-0200 |
| NDA 20-176 | VitaPed (multivitamins) | Hospira, Inc. |
| NDA 20-338 | Differin (adapalene) Solution, 0.1% | Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177 |
| NDA 20-759 | Trovan (trovafloxacin mesylate) Tablets, 100 mg and 200 mg | Pfizer, Inc. |
| NDA 20-760 | Trovan (alatrofloxacin mesylate) Injection | Do. |
| NDA 20-847 | Esclim (estradiol extended-release film) Transdermal System | Women First Healthcare, Inc., 380 Lexington Ave., New York, NY 10168 |
| NDA 20-962 | Emla (2.5% lidocaine and 2.5% prilocaine) Anesthetic Disc | AstraZeneca Pharmaceuticals |
| ANDA 40-023 | Adrucil (fluorouracil injection USP), 50 mg/mL | Sicor Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618 |
| ANDA 40-147 | Leucovorin Calcium Injection USP, 10 mg (base)/mL | Hospira, Inc. |
| NDA 50-039 | Garamycin (gentamicin sulfate) Ophthalmic Solution | Schering Corp. |
| NDA 50-091 | Chloroptic (chloramphenicol ophthalmic solution USP), 0.5% | Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534 |
| NDA 50-322 | Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Sterile Ophthalmic Solution | Merck Co., Inc. |
| NDA 50-368 | Ilotycin (erythromycin) Ophthalmic Ointment | Eli Lilly Co. |
| NDA 50-571 | CefMax (cefmenoxime HCl) Injection | TAP Pharmaceutical Products, Inc., 675 North Field Dr., Lake Forest, IL 60045 |
| NDA 50-648 | Clindamycin Phosphate Injection in 5% Dextrose | Baxter Healthcare Corp., Route 120 Wilson Rd., Round Lake, IL 60073 |
| ANDA 60-429 | Sumycin Capsules (tetracycline HCl capsules USP) | Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 |
| ANDA 62-480 | Gentacidin Solution (gentamicin sulfate ophthalmic solution USP) | Novartis Pharmaceuticals Corp., 1 Health Plaza, Bldg. 118, East Hanover, NJ 07936-1080 |
| ANDA 62-597 | Mytrex (nystatin and triamcinolone acetonide cream USP) 100,000 units/gram (g) and 1 mg/g | Savage Laboratories |
| ANDA 62-601 | Mytrex (nystatin and triamcinolone acetonide ointment USP) 100,000 units/g and 1 mg/g | Do. |
| ANDA 62-750 | Pipracil (piperacillin for injection), 2 g, 3 g, and 4 g | Wyeth Pharmaceuticals, Inc. |
| ANDA 63-186 | Cephalexin Capsules USP, 250 mg and 500 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 64-084 | Sterile Bleomycin Sulfate for Injection USP, 15 and 30 units/vial | Sicor Pharmaceuticals, Inc. |
| ANDA 70-083 | Ibuprofen Tablets USP, 400 mg | BASF Corp. |
| ANDA 70-099 | Ibuprofen Tablets USP, 600 mg | Do. |
| ANDA 70-273 | Alphatrex (betamethasone dipropionate lotion USP), 0.05% | Savage Laboratories |
| ANDA 70-745 | Ibuprofen Tablets USP, 800 mg | BASF Corp. |
| ANDA 72-621 | Acetylcysteine Solution USP, 10% | Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216 |
| ANDA 72-622 | Acetylcysteine Solution USP, 20% | Do. |
| ANDA 72-995 | Metoclopramide HCl Oral Solution, 10 mg/mL | Do. |
| ANDA 73-562 | Diflunisal Tablets USP, 250 mg | Do. |
| ANDA 73-563 | Diflunisal Tablets USP, 500 mg | Do. |
| ANDA 74-166 | Toposar (etoposide injection USP), 20 mg/mL | Sicor Pharmaceuticals, Inc. |
| ANDA 74-541 | Cimetidine HCl Oral Solution, 30 mg/5 mL | Roxane Laboratories, Inc. |
| ANDA 74-663 | Acyclovir Sodium for Injection USP, 500 mg base/vial and 1 g base/vial | Hospira, Inc. |
| ANDA 75-179 | Nabumetone Tablets | Copley Pharmaceutical, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 |
| ANDA 75-875 | Carbamazepine Oral Suspension USP, 100 mg/5 mL | Taro Pharmaceutical Industries, Ltd., c/o Taro Pharmaceuticals, U.S. Agent, 5 Skyline Dr., Hawthorne, NY 10532 |
| ANDA 80-643 | Diphenhydramine HCl Elixir USP, 25 mg/10 mL | Roxane Laboratories, Inc. |
| ANDA 81-225 | Adrucil (etopside injection USP), 50 mg/mL | Sicor Pharmaceuticals, Inc. |
| ANDA 83-261 | Pentobarbital Sodium Injection USP | Wyeth Pharmaceuticals |
| ANDA 83-383 | Diucardin (hydroflumethiazide tablets USP) Tablets, 50 mg | Do. |
| ANDA 84-015 | Bleph-10 (sulfacetamide sodium ophthalmic ointment USP) Ophthalmic Ointment, 10% | Allergan, Inc. |
| ANDA 84-514 | Dilor (dyphylline tablets USP), 200 mg | Savage Laboratories |
| ANDA 84-751 | Dilor-400 (dyphylline tablets USP), 400 mg | Do. |
| ANDA 85-035 | Diphenoxylate HCl and Atropine Sulfate Tablets USP, 2.5 mg and 0.025 mg | R S Pharma, LLC, 8407 Austin Tracy Rd., Fountain Run, KY 42133 |
| ANDA 85-961 | Methocarbamol Tablets USP, 500 mg | Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals, Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 |
| ANDA 85-963 | Methocarbomal Tablets USP, 750 mg | Do. |
| ANDA 86-899 | Isoetharine HCl Inhalation Solution USP, 1% | Roxane Laboratories, Inc. |
| ANDA 87-450 | Chlorthalidone Tablets USP, 50 mg | Clonmel Healthcare Ltd. |
| ANDA 87-451 | Chlorthalidone Tablets USP, 25 mg | Do. |
| ANDA 87-500 | Aminophylline Tablets USP, 100 mg | Roxane Laboratories, Inc. |
| ANDA 87-501 | Aminophylline Tablets USP, 200 mg | Do. |
| ANDA 88-253 | T-Phyl (theophylline) Extended-Release Tablets, 200 mg | The Purdue Frederick Co. |
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 June 16, 2006.
Dated: May 23, 2006.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E6-9440 Filed 6-15-06; 8:45 am]
BILLING CODE 4160-01-S