72 FR 215 pgs. 62858-62863 - Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications
Type: NOTICEVolume: 72Number: 215Pages: 62858 - 62863
Docket number: [Docket No. 2007N-0427]
FR document: [FR Doc. E7-21886 Filed 11-6-07; 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. 2007N-0427]
Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 73 new drug applications (NDAs) and 62 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
EFFECTIVE DATE : December 7, 2007.
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 6-459 | Hetrazan (diethylcarbamaxine citrate) Tablets and Syrup | Lederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 6-799 | Rubramin and Rubramin PC (cyanocobalamin injection USP) | Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000 |
| NDA 7-517 | Tapazole (methimazole tablets USP), 5 milligrams (mg) and 10 mg | King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620 |
| NDA 7-942 | Sus-Phrine (epinephrine) Injection | Forest Laboratories, Inc., Harborside Financial Center, Plaza Three, suite 602, Jersey City, NJ 07311 |
| NDA 9-319 | Ambenyl Expectorant and Ambenyl Cough Syrup | Do. |
| NDA l0-533 | PBZ SR (tripelennamine HCl USP) Extended-Release Tablets | Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080 |
| NDA 10-744 | Darbid (isopropamide iodide) Tablets | SmithKline Beecham Corp., d/b/a/ GlaxoSmith Kline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709 |
| NDA 10-909 | Miradon (anisindione) Tablets | Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 |
| NDA 11-213 | Trilafon (perphenazine) Injection, 5 mg/milliliter (mL) | Do. |
| NDA 11-283 | Kenacort (tramcinolone) Tablets | Bristol-Myers Squibb Co. |
| NDA 11-808 | Mellaril (thioridazine HCl) Tablets | Novartis Pharmaceuticals Corp. |
| NDA 12-145 | Prolixin (fluphenazine HCl) Elixir, 0.5 mg/mL | Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 |
| NDA 12-313 | BIO-CLEAR (dibenzothiophene) Cream | Helena Rubinstein, 202 Rodney Bldg., 3411 Silverside Rd., Wilmington, DE 19810 |
| NDA 12-665 | Velban (vinblastine sulfate) for Injection | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 |
| NDA 12-678 | Tolbutamide Tablets | Sandoz Inc., 227-15 North Conduit Ave., Laurelton, NY 11413 |
| NDA 12-796 | Quinidex Extentabs (quinidine sulfate extended-release tablets USP) | Wyeth Pharmaceuticals, Inc. |
| NDA 14-103 | Oncovin (vincristine sulfate) Injection | Eli Lilly and Co. |
| NDA 14-242 | Dexacort (dexamethasone sodium phosphate) Turbinaire | UCB, 755 Jefferson Rd., Rochester, NY 14623 |
| NDA 14-262 | Solbar (dioxybenzone and oxybenzone) Cream | Person Covey, Inc., 616 Allen Ave., Glendale, CA 91201 |
| NDA 16-363 | Lasix (furosemide) 10-mg/mL Injection | Sanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807-0977 |
| NDA 16-408 | WILDROOT (pyrithione zinc) Hair Groom and Grenadier Hair Groom | Colgate-Palmolive Co., 909 River Rd., Piscataway, NJ 08854-5596 |
| NDA 16-729 | Ferrous Citrate Fe 59 Injection | Mallinckrodt Inc., 675 McDowell Blvd., P.O. Box 5840, St. Louis, MO 63134 |
| NDA 16-820 | Emete-Con (benzquinamide HCl) Injection | Pfizer, Inc., 235 East 42nd St., New York, NY 10017 |
| NDA 16-847 | Isopaque 440 (metrizoate sodium, meglumine metrizoate, calcium metrizoate, and metrizoate magnesium) Injection | GE Healthcare, 101 Carnegie Center, Princeton, NJ 08540 |
| NDA 17-430 | Neggram (nalidixic acid USP) Suspension | Sanofi-Aventis |
| NDA 17-466 | Bricanyl (terbutaline sulfate) Injection | Sanofi-Aventis |
| NDA 17-506 | Isopaque 280 (metrizoic acid, meglumine, and calcium) Injection | GE Healthcare |
| NDA 17-613 | Lotrimin (clotrimazole) Topical Solution, 1% | Schering Corp. |
| NDA 17-618 | Bricanyl (terbutaline sulfate) Tablets | Sanofi-Aventis |
| NDA 17-619 | Lotrimin (clotrimazole) Cream, 1% | Schering Corp. |
| NDA 17-668 | Tenuate (diethylpropion HCl) Tablets, 25 mg | Sanofi-Aventis |
| NDA 17-669 | Tenuate (diethylpropion HCl) Extended-Release Tablets, 75 mg | Sanofi-Aventis |
| NDA 17-688 | Lasix (furosemide) Oral Solution, 10 mg/mL | Sanofi-Aventis |
| NDA 17-719 | Dimeray (iocarmate meglumine) Injection | Mallinckrodt Inc. |
| NDA 17-725 | Sodium Pertechnetate Tc-99m (technectium Tc-99m sodium pertechnetate) | Mallinckrodt Inc. |
| NDA 17-730 | Isopaque 370 (metrizoic acid and meglume) Injection | GE Healthcare |
| NDA 17-769 | Calcimar (calcitonin salmon) Injection | Sanofi-Aventis |
| NDA 17-838 | Lungaggregate Reagent | GE Healthcare |
| NDA 17-848 | Tc-99m Lungaggregate | Do. |
| NDA 17-907 | Glucoscan Kit for the Preparation of Technetium Tc-99m Gluceptate | Bristol-Myers Squibb Pharma Co., Chestnut Run Plaza, 974 Centre Rd., Wilmington, DE 19805 |
| NDA 17-923 | Mellaril-S (thioridazine HCl) Oral Suspension | Novartis Pharmaceuticals Corp. |
| NDA 17-956 | Tepanil (diethylpropion HCl) Ten-Tabs | 3M Pharmaceuticals, 3M Center, Bldg 0275-05-W-12, St. Paul, MN 55144-1000 |
| NDA 18-000 | Bricanyl (terbutaline sulfate) Inhaler | Sanofi-Aventis |
| NDA 18-067 | Cinobac (cinoxacin) Capsules, 250 mg and 500 mg | Eli Lilly and Co. |
| NDA 18-088 | Krypton Kr-81m Gas Generator | GE Healthcare |
| NDA 18-148 | Nasalide (flunisolide) Nasal Spray | IVAX Research, Inc., 4400 Biscayne Blvd., Miami, FL 33137 |
| NDA 18-489 | Technescan HIDA (kit for the preparation of technetium Tc-99m lidofenin injection) | Draximage, 16751 Autoroute TransCanada Highway, Kirkland, Quebec, H9H 4J4, Canada |
| NDA 18-519 | Irrigation Solution G (citric acid and sodium carbonate) | Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085 |
| NDA 18-554 | Eulexin (flutamide) Capsules | Schering Corp. |
| NDA 18-700 | Inocor (inamrinone lactate) Injection, 5 mg base/mL | Sanofi-Synthelabo Inc., c/o Sanofi-Aventis, 300 Somerset Corporate Blvd., P.O. Box 6977, Bridgewater, NJ 08807-0977 |
| NDA 18-770 | Tornalate (bitolterol mesylate) Metered-Dose Inhaler | Sanofi-Aventis |
| NDA 18-813 | Lotrimin (clotrimazole) Lotion, 1% | Schering Corp. |
| ANDA 18-862 | Betatrex (betamethasone valerate cream USP, 0.1%) | Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 |
| ANDA 18-863 | Betatrex (betamethasone valerate ointment USP, 0.1%) | Do. |
| ANDA 18-867 | Betatrex (betamethasone valerate lotion USP, 0.1%) | Do. |
| NDA 19-084 | Nizoral (ketoconazole) Cream, 2% | Johnson Johnson Pharmaceutical Research Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560 |
| NDA 19-284 | Oral Colonic Lavage (OCL) (sodium chloride, sodium bicarbonate, sodium sulfate, potassium chloride, and polyethelene glycol 3350) | Hospira, Inc., 275 North Field Dr., Bldg. 2-J45-2, Lake Forest, Il 60045-5046 |
| NDA 19-408 | Diprolene (betamethasone dipropionate) | Schering Corp. |
| NDA 19-459 | Photoplex (7% padimate O and 3% avobenzone) Lotion | Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534 |
| NDA 19-520 | Travasol (amino acid) in Dextrose Injection | Baxter Healthcare Corp. |
| NDA 19-545 | Didronel (etidronate disodium) Injection | MGI Pharma, Inc., 5775 West Old Shakopee Rd., suite 100, Bloomington, MN 55437-3174 |
| NDA 19-548 | Tornalate (bitolterol mesylate) Inhalatioon Solution, 0.2% | Sanofi-Aventis |
| NDA 19-576 | Nizoral (ketoconazole) Cream, 2% | Johnson Johnson Pharmaceutical Development, LLC |
| NDA 19-648 | Nizoral (ketoconazole) Cream, 2% | Do. |
| NDA 20-091 | Imagent (perflubron) | Alliance Pharmaceuticals Corp., 4660 La Jolla Dr., suite 740, San Diego, CA 92122 |
| NDA 20-147 | Travasol (amino acid) with Electrolytes in Dextrose Injection | Baxter Healthcare Corp. |
| NDA 20-228 | Atrovent (ipratropium bromide) Inhalation Solution | Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 |
| NDA 20-303 | Prempro/Premphase (conjugated estrogens and medroxyprogesterone acetate) Tablets | Wyeth Pharmaceuticals, Inc. |
| NDA 20-315 | Orlaam (levomethadyl acetate HCl) Oral Solution | Roxane Laboratories, P.O. Box 16532, Columbus, OH 43216-6532 |
| NDA 20-486 | Vanceril (beclomethasone dipropionate) Double Strength Aerosol | Schering Corp. |
| NDA 20-887 | AcuTect Kit for the Preparation of Technetium Tc-99m Apticide Injection | CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730 |
| NDA 21-012 | Neo-Tect Kit for the Preparation of Technetium Tc-99m Depreotide Injection | Do. |
| NDA 21-075 | Nutropin Depot (somatropin recombinant) | Genentech Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990 |
| ANDA 40-098 | Acetaminophen and Codeine Phosphate Oral Solution USP | Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 |
| NDA 50-477 | Nebcin (tobramycin sulfate) for Injection | Eli Lilly and Co. |
| NDA 50-519 | Nebcin (tobramycin sulfate) for Injection | Do. |
| NDA 50-678 | Dynabac (dirithromycin delayed-release tablets USP) | Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 |
| ANDA 60-212 | Grisactin (griseofulvin microcrystalline) Tablets, 500 mg | Wyeth Ayerst Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101 |
| ANDA 60-570 | Fungizone (amphotericin B lotion USP), 3% | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 60-751 | NEO-CORTEF (neomycin sulfate and hydrocortisone acetate) Ointment | Pharmacia Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017 |
| ANDA 61-007 | Terramycin (oxytetracycline HCl, polymyxin B sulfate) Topical Ointment with Polymyxin B Sulfate | Pfizer, Inc. |
| ANDA 61-131 | Nystatin Powder USP | Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. |
| ANDA 61-411 | Veetids (penicillin V potassium tablets USP), 250 mg and 500 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 61-737 | ZIBA-Rx (bacitracin zinc USP) | X-GEN Pharmaceuticals, Inc., P.O. Box 1148, Elmira, NY 14902 |
| ANDA 61-859 | Anspor (cephradine) Capsules, 250 mg and 500 mg | GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 |
| ANDA 61-866 | Anspor (cephradine) for Oral Suspension | Do. |
| ANDA 61-876 | Cerubidine Injection (daunorubice HCl for injection USP) | Sanofi-Aventis |
| ANDA 62-519 | Nystex (nystatin) Oral Suspension USP, 100,000 units/mL | Savage Laboratories |
| ANDA 62-560 | Mandol (cefamadole nafate for injection USP) | Eli Lilly and Co. |
| ANDA 62-739 | Tazidime (ceftazidime) | Do. |
| ANDA 62-745 | Cephalexin Tablets USP | Do. |
| ANDA 62-888 | Principen (ampicillin capsules USP), 250 mg and 500 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 62-926 | Rubex (doxorubicin HCl for injection USP) | Bristol-Myers Squibb Co. |
| ANDA 63-021 | Kanamycin Sulfate Injection USP, 75 mg/2 mL | Loch Pharmaceuticals, c/o Bedford Laboratories, A Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146 |
| ANDA 63-022 | Kanamycin Sulfate Injection USP, 500 mg/2 mL | Do. |
| ANDA 63-025 | Kanamycin Sulfate Injection USP, 1 gram (g)/3 mL | Do. |
| ANDA 63-099 | Trimox (amoxicillin capsules USP), 250 mg and 500 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 70-867 | Vincrex (vincristine sulfate for injection USP), 5 mg/vial | Bristol-Myers Squibb Co. |
| ANDA 71-742 | Clorazepate Dipotassium Capsules, 3.75 mg | Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. |
| ANDA 71-743 | Clorazepate Dipotassium Capsules, 7.5 mg | Do. |
| ANDA 71-744 | Clorazepate Dipotassium Capsules, 15 mg | Do. |
| ANDA 72-326 | Fenoprofen Calcium Tablets USP, 600 mg | Do. |
| ANDA 72-507 | Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg | Do. |
| ANDA 72-508 | Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg | Do. |
| ANDA 72-509 | Methyldopa and Hydrochlorothiazide Tables USP, 500 mg/30 mg | Do. |
| ANDA 72-510 | Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg | Do. |
| ANDA 72-705 | Prazosin HCl Capsules USP, 1 mg | Do. |
| ANDA 72-706 | Prazosin HCl Capsules USP, 2 mg | Do. |
| ANDA 72-707 | Prazosin HCL Capsules USP, 5 mg | Do. |
| ANDA 74-258 | Metoprolol Tartrate Tablets USP, 50 mg and 100 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 74-423 | Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg | Clonmel Healthcare, Ltd., c/o of STADA Pharmaceuticals Inc. |
| ANDA 74-472 | Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 75-407 | Morphine Sulfate Extended-Release Tablets USP, 15 mg | Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. |
| ANDA 80-745 | Aristocort (triamcinolone acetonide) Ointment, 0.5% | Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2537 |
| ANDA 80-750 | Aristocort (triamcinolone acetonide) Ointment, 0.1% | Do. |
| ANDA 83-015 | Aristocort (triamcinolone acetonide) Cream, 0.5% | Do. |
| ANDA 83-016 | Aristocort (triamcinolone acetonide) Cream, 0.1% | Do. |
| ANDA 83-017 | Aristocort (triamcinolone acetonide) Cream, 0.025% | Do. |
| ANDA 83-149 | PBZ (tripelennamine HCl) Tablet, 25 mg | Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936-1080 |
| ANDA 83-317 | Propoxyphene HCl Capsules, 65 mg | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 |
| ANDA 83-380 | Aristogel (triamcinolone acetonide) Gel, 0.1% | Astellas Pharma US, Inc. |
| ANDA 83-881 | Aristocort A (triamcinolone acetonide) Spray | Do. |
| ANDA 86-212 | Chlordiazepoxide HCl Capsules, 25 mg | Impax Laboratories, Inc. |
| ANDA 86-213 | Chlordiazepoxide Capsules, 5 mg | Do. |
| ANDA 86-358 | Mexate (methotrexate sodium for injection) | Bristol-Myers Squibb Co. |
| ANDA 86-926 | Tolbutamide Tablets USP, 500 mg | Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. |
| ANDA 87-011 | Quinidine Sulfate Tablets USP, 200 mg | Do. |
| ANDA 87-677 | Hydrocodone Bitartrate and Acetaminophen | B.F. Ascher Co., Inc., 15501 West 109th St., Lenexa, KS 66219 |
| ANDA 87-887 | TRYSUL (triple sulfa vaginal cream USP) | Savage Laboratories |
| ANDA 88-584 | DHC Plus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules | The Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431 |
| ANDA 88-760 | Mexate-AQ (methotrexate sodium injection USP), 25 mg | Bristol-Myers Squibb Co. |
| ANDA 88-780 | Aristocort A Ointment (triamcinolone acetonide ointment USP), 0.1% | Astellas Pharma US, Inc. |
| ANDA 88-781 | Aristocort A (triamcinolone acetonide) Ointment, 0.5% | Do. |
| ANDA 88-944 | Sedapap (butalbital and acetaminophen) Tablets, 50 mg/650 mg | Merz Pharmaceuticals, LLC, 4215 Tudor Lane, Greensboro, NC 27410 |
| ANDA 89-887 | Mexate-AQ Preserved (methotrexate sodium injection USP), 25 mg/mL | Bristol-Myers Squibb 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, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective December 7, 2007.
Dated: October 26, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-21886 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S