74 FR 95 pgs. 23407-23412 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
Type: NOTICEVolume: 74Number: 95Pages: 23407 - 23412
Docket number: [Docket No. FDA-2009-N-0211]
FR document: [FR Doc. E9-11628 Filed 5-18-09; 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. FDA-2009-N-0211]
Novartis Pharmaceuticals 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) 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 18, 2009.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-796-3601.
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 6-403 | Priscoline (tolazoline hydrochloride (HCl) | Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080 |
| NDA 8-303 | Apresoline (hydralazine HCl) | Do. |
| NDA 9-087 | Hydergine (ergoloid mesylates) Sublingual Tablets | Do. |
| NDA 9-509 | Aramine (metaraminol bitartrate) Injection, 10 milligrams (mg)/milliliter (mL) | Merck Co., Inc., UG2C-50, P.O. Box 1000, North Wales, PA 19454-1099 |
| NDA 9-987 | Delta-Cortef (prednisolone) Tablets | Pharmacia Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York, NY 10017 |
| NDA 10-060 | Florinef (fludrocortisone acetate) Tablets | King Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620 |
| NDA 10-392 | Atarax (hydroxyzine HCl) Tablets | Pfizer, Inc., 235 East 42d St., New York, NY 10017 |
| NDA 10-485 | Atarax (hydroxyzine HCl) Syrup | Roerig Pharmaceuticals, c/o Pfizer, Inc. |
| NDA 10-571 | Compazine (prochlorperazine maleate) Tablets | GlaxoSmithKline, 1250 South Collegeville Rd., UP4110, Collegeville, PA 19426 |
| NDA 10-611 | Halotestin (fluoxymesterone) Tablets, 2 mg, 5 mg, and 10 mg | Pharmacia Upjohn Co., c/o Pfizer, Inc. |
| NDA 10-686 | Moderil (rescinnamine) Tablets, 0.25 mg and 0.5 mg | Pfizer, Inc. |
| NDA 10-742 | Compazine (prochlorperazine edisylate) Injection | GlaxoSmithKline |
| NDA 10-976 | Enovid/Enovid-E/Enovid-E 21 (norethynodrel and mestranol) Tablets | G.D. Searle LLC, c/o Pfizer, Inc. |
| NDA 11-000 | Compazine (prochlorperazine maleate) Extended-Release Capsules | GlaxoSmithKline |
| NDA 11-111 | Vistaril (hydroyzine HCl) Injection | Pfizer, Inc. |
| NDA 11-127 | Compazine (prochlorperazine) Suppositories | GlaxoSmithKline |
| NDA 11-188 | Compazine (prochlorperazine edisylate) Syrup | Do. |
| NDA 11-556 | Anturane (sulfinpyrazone) Tablets and Capsules | Novartis Pharmaceuticals Corp. |
| NDA 11-635 | Diupres (chlorothiazide and reserpine) Tablets | Merck Co., Inc. |
| NDA 11-793 | Esidrix (hydrochlorothiazide) Tablets | Novartis Pharmaceuticals Corp. |
| NDA 11-838 | Tofranil (imipramine HCl) Injection | Do. |
| NDA 12-193 | Ser-Ap-Es (reserpine, hydralazine HCl, and hydrochlorothiazide) Tablets | Do. |
| NDA 12-329 | Ismelin (guanethidine monosulfate) Tablets | Do. |
| NDA 12-753 | Torecan (thiethylperazine maleate) Tablets, 10 mg | Do. |
| NDA 12-754 | Torecan (thiethylperazine maleate) Injection, 5 mg/mL | Do. |
| NDA 12-791 | Hypertensin (angiotensin amide) Injection | Do. |
| NDA 12-845 | Renese (polythiazide) Tablets, 1 mg, 2 mg, and 4 mg | Pfizer, Inc. |
| NDA 13-636 | Renese-R (polythiazide and reserpine) Tablets, 2 mg/0.25 mg | Do. |
| NDA 15-500 | Tolinase (tolazamide) Tablets | Pharmacia Upjohn Co., c/o Pfizer, Inc. |
| NDA 16-029 | Ovulen (ethynodiol diacetate and mestranol) Tablets | G.D. Searle LLC, c/o Pfizer, Inc. |
| NDA 16-126 | Primatene (epinephrine bitartrate) Mist, 0.2 mg, and Bronitin (epinephrine bitartrate) Mist, 0.3 mg | Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940 |
| NDA 16-635 | Cyanocobalamin CO-57 Schilling Test Kit | Mallinckrodt Medical, c/o Mallinckrodt, Inc., 675 McDonnell Blvd., Hazelwood, MO 63042 |
| NDA 16-705 | Ovulen-28 (ethynodiol diacetate and mestranol) Tablets | G.D. Searle LLC, c/o Pfizer, Inc. |
| NDA 16-709 | Ortho-Novum 1/50-28 (norethindrone and mestranol) Tablets | Ortho-McNeil-Janssen Pharmaceutical, Inc., c/o Johnson Johnson Pharmaceutical Research Development, LLC, 920 Rt. 202, P.O. Box 300, Raritan, NJ 08869 |
| NDA 16-758 | Navane (thiothixene HCl) Oral Concentrate | Pfizer, Inc. |
| NDA 16-834 | Lithane (lithium carbonate) Tablets | Do. |
| NDA 16-904 | Navane (thiothixene HCl) Injection | Do. |
| NDA 17-059 | TechneColl (technetium Tc-99m sulfur colloid kit) | Mallinckrodt Medical, c/o Mallinckrodt, Inc. |
| NDA 17-247 | Sanorex (mazindol) Tablets | Novartis Pharmaceuticals Corp. |
| NDA 17-476 | Slow-K (potassium chloride) Extended-Release Tablets | Do. |
| NDA 17-543 | Ludiomil (maprotiline HCl) Tablets, 25 mg, 50 mg, and 75 mg | Novartis Pharmaceuticals Corp. |
| NDA 17-551 | Perchloracap (potassium perchlorate) Capsules | Mallinckrodt Medical, c/o Mallinckrodt, Inc. |
| NDA 17-842 | TechneScan MAA (technetium Tc-99m albumin aggregate kit) | Do. |
| NDA 17-844 | Radioiodinated Serum Albumin (Human) IHSA I-125 (iodinated I-125 albumin injection) | Do. |
| NDA 17-851 | Lioresal (baclofen) Tablets, 10 mg and 20 mg | Novartis Pharmaceuticals Corp. |
| NDA 17-971 | Eskalith (lithium carbonate) Tablets, 300 mg | JDS Pharmaceuticals, LLC, c/o Noven Pharmaceuticals, Inc., 11960 SW. 44th St., Miami, FL 33186 |
| NDA 17-986 | Minizide (prazosin HCl and polythiazide) Capsules, 1 mg, 2 mg, and 5 mg | Pfizer, Inc. |
| NDA 18-006 | Meclomen (meclofenamate sodium) Capsules, 50 mg and 100 mg | Parke-Davis, a subsidiary of Pfizer, Inc. |
| NDA 18-152 | Eskalith CR (lithium carbonate) Controlled-Release Tablets, 450 mg | JDS Pharmaceuticals, LLC, c/o Noven Pharmaceuticals, Inc. |
| NDA 18-202 | Cytadren (aminoglutethimide) Tablets | Novartis Pharmaceuticals Corp. |
| NDA 18-245 | Syntocinon (oxytocin) Injection | Do. |
| NDA 18-249 | Sodium Lactate Injection USP | Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046 |
| NDA 18-272 | Technescan Gluceptate (technetium Tc-99m gluceptate kit) | Draximage, a division of DRAXIS Specialty Pharmaceuticals, Inc., 16751 Autoroute TransCanada Highway, Kirkland, Qu. Canada H9H 4J4 |
| NDA 18-285 | Visken (prindolol) Tablets | Novartis Pharmaceuticals Corp. |
| NDA 18-535 | Diulo (metolazone) Tablets, 2.5 mg, 5 mg, and 10 mg | G.D. Searle LLC, c/o Pfizer, Inc. |
| NDA 18-536 | Xenon Xe-127 Gas | Mallinckrodt, Inc. |
| NDA 18-904 | Urologic G (citric acid, sodium carbonate, and magnesium oxide) Irrigation in Plastic Containers | Hospira, Inc. |
| NDA 19-650 | Flumadine (rimantadine HCl) Syrup | Forest Laboratories, Inc., Harborside Financial Center III, suite 602, Jersey City, NJ 07311 |
| NDA 19-672 | Efidac 24 Pseudoephedrine/Brompheniramine (pseudoephedrine HCl and brompheniramine maleate) Extended-Release Tablets | Alza Corp., 1900 Charleston Rd., P.O. Box 7210, Mountain View, CA 94039-7210 |
| NDA 19-721 | Norditropin (somatropin recombinant) for Injection | Novo Nordisk Inc., 100 College Rd. West, Princeton, NJ 08540 |
| NDA 19-746 | Efidac 24 Chlorpheniramine (chlorpheniramine maleate) Extended-Release Tablets | Alza Corp. |
| NDA 19-753 | Ethmozine (moricizine HCl) Tablets | Shire Development, Inc., 725 Chesterbrook Blvd., Wayne, PA 19087 |
| NDA 19-762 | Testoderm (testosterone) and Testoderm with Adhesive | Alza Corp. |
| NDA 19-775 | Minipress XL (prazosin HCl) Extended-Release Tablets | Pfizer, Inc. |
| NDA 19-794 | Depakote CP (divalproex sodium) Delayed-Release Tablets | Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60664-6157 |
| NDA 19-863 | Geref Diagnostic (sermorelin acetate) for Injection | EMD Serono, Inc., One Technology Dr., Rockland, MA 02370 |
| NDA 19-983 | Prostep (nicotine) Transdermal System, 11 mg/24 hour (h) and 22 mg/24 h | Aveva Drug Delivery Systems, Inc., 3250 Commerce Pkwy., Miramar, FL 33025 |
| NDA 20-013 | Maxaquin (lomefloxacin HCl) Tablets | Pharmacia Upjohn Co., c/o Pfizer, Inc. |
| NDA 20-044 | Exosurf Neonatal (colfosceril palmitate, cetyl alcohol, and tyloxapol) Powder for Suspension | GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398 |
| NDA 20-087 | Floxin (ofloxacin) Solution for Injection | Ortho-McNeil Pharmaceutical, Inc., c/o Johnson Johnson Pharmaceutical Research Development, LLC |
| NDA 20-137 | Demadex (torsemide) Injection | Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199 |
| NDA 20-144 | Transderm-Nitro (nitroglycerin) | Novartis Pharmaceuticals Corp. |
| NDA 20-154 | Videx (didanosine) Chewable Tablets | Bristol-Meyers Squibb, 5 Research Pkwy., Signature 91 Bldg., Wallingford, CA 06492 |
| NDA 20-155 | Videx (didanosine) Buffered Powder for Oral Solution | Do. |
| NDA 20-199 | Hivid (zalcitabine) Tablets | Hoffman-La Roche, Inc. |
| NDA 20-250 | Halfan (halofantrine HCl) Tablets | GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 |
| NDA 20-306 | Fludeoxyglucose F-18 Injection | Downstate Clinical PET Center-Methodist Medical Center of Illinois, 221 NE. Glen Oak Ave., Peoria, IL 61636-0002 |
| NDA 20-443 | Geref (sermorelin acetate) for Injection | EMD Serono, Inc. |
| NDA 20-545 | Procanbid (procainamide HCl) Extended-Release Tablets, 500 mg and 1,000 mg | King Pharmaceuticals, Inc. |
| NDA 20-686 | LumenHance (manganese chloride tetrahydrate) for Solution | Bracco Diagnostics Inc., 107 College Rd. East, Princeton, NJ 08540 |
| NDA 20-773 | SonoRX (simethicone coated cellulose) Suspension | Do. |
| NDA 20-791 | Testoderm TTS (testosterone transdermal system), 5 mg/24 h | Alza Corp. |
| NDA 21-019 | Compazine (prochlorperazine maleate) Extended-Release Capsules | GlaxoSmithKline, Collegeville, PA 19426 |
| NDA 21-868 | Exubera (insulin recombinant human) Inhalation Powder, 1 mg and 3 mg | Pfizer, Inc. |
| ANDA 40-092 | Digoxin Injection USP, 0.1 mg/mL | Hospira, Inc. |
| NDA 50-109 | Mithracin (plicamycin) Injection, 2.5 mg | Pfizer, Inc. |
| NDA 50-286 | Terramycin (oxytetracycline HCl) Capsules | Do. |
| NDA 50-316 | Lincocin (lincomycin HCl) Capsules, 250 mg and 500 mg | Pharmacia Upjohn Co., c/o Pfizer, Inc. |
| NDA 50-461 | Ancef (cefazolin) for Injection | SmithKline Beecham, d/b/a GlaxoSmithKline, Philadelphia, PA 19101-7929 |
| NDA 50-529 | Pediazole (erythromycin ethylsuccinate and sulfisoxazole acetyl) for Oral Suspension | Ross Products Division, Abbott Laboratories, 3300 Stelzer Rd., Columbus, OH 43219-3034 |
| NDA 50-613 | Cefobid (cefoperazone sodium) Injection | Pfizer, Inc. |
| NDA 50-667 | Lorabid (loracarbef for oral suspension USP), 100 mg/5 mL and 200 mg/5 mL | King Pharmaceuticals, Inc. |
| NDA 50-763 | Mitozytrex (mitomycin) for Injection, 5 mg/vial | SuperGen, Inc., 4140 Dublin Blvd., suite 200, Dublin, CA 94568 |
| ANDA 61-014 | Terramycin (oxytetracycline HCl) Ophthalmic Solution | Pfizer, Inc. |
| ANDA 61-229 | Polysporin Ophthalmic Ointment (bacitracin zinc and polymyxin B sulfate ophthalmic ointment) | Monarch Pharmaceuticals, Inc. (a wholly-owned subsidiary of King Pharmaceuticals, Inc.), 501 5th St., Bristol, TN 37620 |
| ANDA 64-099 | Amikacin Sulfate Injection USP, 250 mg/mL | Hospira, Inc. |
| ANDA 70-252 | Naloxone HCl Injection USP, 0.02 mg/mL | Do. |
| ANDA 70-253 | Naloxone HCl Injection USP, 0.02 mg/mL | Do. |
| ANDA 71-166 | Bupivacaine HCl and Epinephrine Injection USP | Do. |
| ANDA 71-169 | Bupivacaine HCl and Epinephrine Injection USP | Do. |
| ANDA 71-171 | Bupivacaine HCl and Epinephrine Injection USP | Do. |
| ANDA 73-685 | Acilac (lactulose solution USP), 10 grams (g)/15 mL | Nostrum Laboratories, Inc., 1800 North Topping Ave., Kansas City, MO 64120 |
| ANDA 73-686 | Laxilose (lactulose solution USP), 10 g/15 mL | Do. |
| ANDA 74-083 | Nitroglycerin in 5% Dextrose Injection, 0.1 mg/mL | Hospira, Inc. |
| ANDA 74-127 | Atenolol Tablets USP, 50 mg and 100 mg | Nostrum Laboratories, Inc. |
| ANDA 74-337 | Furosemide Injection USP, 10 mg/mL | Hospira, Inc. |
| ANDA 74-391 | Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mg | Roxane Laboratories, Inc., 1809 Wilson Rd., P.O. Box 16532, Columbus, OH 43216-6532 |
| ANDA 74-403 | Dopamine HCl Injection USP, 40 mg/mL | Hospira, Inc. |
| ANDA 74-404 | Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and 100 mg/25 mg | Nostrum Laboratories, Inc. |
| ANDA 74-474 | Pindolol Tablets USP, 5 mg and 10 mg | Do. |
| ANDA 74-740 | Atracurium Besylate Injection USP, 10 mg/mL | Hospira, Inc. |
| ANDA 74-741 | Atracurium Besylate Injection USP, 10 mg/mL | Do. |
| ANDA 75-088 | Cromoptic (cromolyn sodium) Ophthalmic Solution, 4% | King Pharmaceuticals, Inc. |
| ANDA 75-162 | Clozapine Tablets USP, 25 mg and 100 mg | Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977 |
| ANDA 75-466 | Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mg | Genpharm Inc., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504-4310 |
| ANDA 75-558 | Vecuronium Bromide for Injection, 4 mg/Ampul | Hospira, Inc. |
| ANDA 75-762 | Ofloxacin Injection, 40 mg/mL | Bedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146 |
| ANDA 75-899 | Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg | Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709 |
| ANDA 76-138 | Ciprofloxacin HCl Tablets USP, 250 mg, 500 mg, and 750 mg | Nostrum Laboratories, Inc. |
| ANDA 76-213 | Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg | Roxane Laboratories, Inc. |
| ANDA 76-270 | Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mg | Do. |
| ANDA 76-476 | Benazepril HCl Tablets, 5 mg, 10 mg, 20 mg, and 40 mg | Mylan Pharmaceuticals, Inc. |
| ANDA 76-489 | Anagrelide HCl Capsules, 0.5 mg and 1 mg | Roxane Laboratories, Inc. |
| ANDA 77-249 | Oxandrolone Tablets USP, 2.5 mg and 10 mg | Do. |
| ANDA 77-445 | Polyethylene Glycol 3350 Powder for Oral Solution | Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454 |
| ANDA 77-648 | Zonisamide Capsules, 25 mg, 50 mg, and 100 mg | Roxane Laboratories, Inc. |
| ANDA 78-026 | Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg, and 40 mg | Do. |
| ANDA 81-008 | Strifon Forte DSC (chlorzoxazone tablets USP), 500 mg | Ferndale Laboratories, 780 West 8th Mile Rd., Ferndale, MI 48220 |
| ANDA 81-095 | Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/15 mg | Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318 |
| ANDA 83-283 | Isoproterenol HCl Injection USP, 0.02 mg/mL | Hospira, Inc. |
| ANDA 83-838 | Promethazine HCl Injection USP | Do. |
| ANDA 84-074 | Bethanechol Chloride Tablets USP, 25 mg | Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136 |
| ANDA 84-702 | Bethanechol Chloride Tablets USP, 5 mg | Do. |
| ANDA 84-712 | Bethanechol Chloride Tablets USP, 10 mg | Do. |
| ANDA 84-735 | Apresazide (hydralazine HCl and hydrochlorothiazide) Capsules, 25 mg/25 mg | Novartis Pharmaceuticals Corp. |
| ANDA 84-810 | Apresazide (hydralazine HCl and hydrochlorothiazide) Capsules, 50 mg/50 mg | Do. |
| ANDA 86-366 | Acetaminophen and Codeine Phosphate Oral Solution USP, 120 mg/12 mg per 5 mL | Roxane Laboratories, Inc. |
| ANDA 87-563 | Quibron-T/SR (theophylline) Extended-Release Tablets, 300 mg | Monarch Pharmaceuticals, Inc. |
| ANDA 88-126 | Aminophylline Oral Solution USP, 105 mg/5 mL | Roxane Laboratories, Inc. |
| ANDA 88-656 | Quibron-T (theophylline) Tablets, 300 mg | Monarch Pharmaceuticals, Inc. |
| ANDA 89-650 | Lidocaine HCl and Epinephrine Injection USP | Hospira, Inc. |
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 18, 2009.
Dated: April 30, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-11628 Filed 5-18-09; 8:45 am]
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