70 FR 42 pgs. 10651-10657 - Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications
Type: NOTICEVolume: 70Number: 42Pages: 10651 - 10657
Docket number: [Docket No. 2005N-0058]
FR document: [FR Doc. 05-4158 Filed 3-3-05; 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. 2005N-0058]
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 76 new drug applications (NDAs) and 60 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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:
April 4, 2005.
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 6-095 | Tubocurarine Chloride Injection | Hospira, Inc., 275 North Field Dr., Bldg. 2-J45-2, Lake Forest, IL 60045-5046 |
| NDA 6-412 | Decapryn (doxylamine succinate) Tablets and Syrup | Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., Bridgewater, NJ 08807-0890 |
| NDA 6-460 | Protamine Sulfate Injection USP | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 |
| NDA 8-032 | Telepaque (iopanoic acid) Tablets | Amersham Health, 101 Carnegie Center, Princeton, NJ 08540 |
| NDA 10-288 | Betadine (10% povidone iodine) Solution and Isodine (10% povidone iodine) Solution | The Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431 |
| NDA 11-097 | Dimetane (brompheniramine maleate) Elixir | Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940 |
| NDA 11-270 | Furoxone (furazolidone) Tablets | Shire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850 |
| NDA 11-323 | Furoxone (furazolidone) Oral Suspension | Do. |
| NDA 11-325 | Vesprin (triflupromazine hydrochloride (HCl)) Injection, 10 milligrams (mg)/milliliter (mL) and 20 mg/mL | Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 |
| NDA 11-367 | Enzactin (triacetin) Spray | Wyeth Consumer Healthcare |
| NDA 12-265 | Naqua (trichlormethiazide) Tablets and Naquival (trichlormethiazide and reserpine) Tablets | Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 |
| NDA 12-320 | Rauzide (rauwolfia serpentine with bendroflumethiazide) Tablets and Rautrax-N Tablets | Apothecon, c/o Bristol-Myers Squibb Co. |
| NDA 12-728 | Ortho-Novum 1/50-21 (norethindrone and mestranol) Tablets | Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson Johnson Research and Development, L.L.C., 920 Route 202 South, Box 300, Raritan, NJ 08869-0602 |
| NDA 16-993 | Adsorbotear Ophthalmic Solution | Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134 |
| NDA 17-471 | Sodium Pertechnetate Tc-99m (technetium Tc-99m sodium pertechnetate) Solution | Amersham Health |
| NDA 17-488 | Modicon 21 (norethindrone and ethinyl estradiol) Tablets | Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson Johnson Research and Development, L.L.C. |
| NDA 17-489 | Ortho-Novum 1/35-21 (norethindrone and ethinyl estradiol) Tablets and Neocon Tablets (norethindrone and ethinyl estradiol) | Do. |
| NDA 17-561 | Celstone (betamethasone sodium phosphate USP) Injection | Schering Corp. |
| NDA 17-601 | Optimine (azatadine maleate USP) Tablets | Do. |
| NDA 17-603 | Novafed ER (pseudoephedrine HCl) Tablets, 120 mg | Aventis Pharmaceuticals, Inc. |
| NDA 17-657 | Cephulac (lactulose fumarate) Syrup | Do. |
| NDA 17-661 | Tavist (clemastine fumarate) Tablets and Tavist-1 (clemastine fumarate) Tablets | Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054-0622 |
| NDA 17-687 | Xenon Xe-133 Gas | Amersham Health |
| NDA 17-700 | Gallium Citrate Ga-67 Injection | Do. |
| NDA 17-773 | Technetium Tc-99m MAA Kit | Amersham Health |
| NDA 17-884 | Chronulac (lactulose) Syrup | Aventis Pharmaceuticals, Inc. |
| NDA 18-030 | Dextrose and Sodium Chloride (NaCl) Injection USP | B. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623-9791 |
| NDA 18-062 | Proventil (albuterol sulfate) Syrup | Schering Corp. |
| NDA 18-229 | Dextrose and NaCl Injection USP | B. Braun Medical, Inc. |
| NDA 18-269 | Isolyte E (multi-electrolyte injection) with 5% Dextrose | Do. |
| NDA 18-270 | Isolyte M (multi-electrolyte injection) with 5% Dextrose | Do. |
| NDA 18-271 | Isolyte R (multi-electrolyte injection) with 5% Dextrose | Do. |
| NDA 18-273 | Isolyte H (multi-electrolyte injection) with 5% Dextrose | Do. |
| NDA 18-335 | Amerscan (technetium Tc-99m medronate) MDP Kit | Amersham Health |
| NDA 18-358 | Dextrose Injection USP, 2.5% | B. Braun Medical, Inc. |
| NDA 18-386 | Dextrose and NaCl Injection USP | Do. |
| NDA 18-506 | Trinalin Repetabs (azatadine maleate and pseudoephedrine sulfate tablets) | Schering Corp. |
| ANDA 18-621 | Nitro-Bid IV (nitroglycerin) Injection, 5 mg/mL | Aventis Pharmaceuticals, Inc. |
| NDA 18-654 | Versed (midazolam HCl) Injection | Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199 |
| NDA 18-675 | Tavist (clemastine fumarate) Syrup | Novartis Consumer Health, Inc. |
| ANDA 18-889 | Metronizadole in NaCl Injection | Abbott Laboratories, 200 Abbott Park Rd., D-389 J45-2, Abbott Park, IL 60064-6133 |
| NDA 18-899 | Isolyte E (multi-electrolyte injection) | B. Braun Medical, Inc. |
| NDA 18-924 | Aminophylline in 0.45% NaCl Injection | Hospira, Inc. |
| NDA 18-967 | Lidocaine HCl and 5% Dextrose Injection | B. Braun Medical, Inc. |
| NDA 19-004 | Ortho-Novum (nonrethindrone and ethinyl estradiol) 7/14-21 and -28 Tablets | Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson Johnson Research and Development, L.L.C. |
| NDA 19-006 | Isolyte S, pH 7.4 (multi-electrolyte injection) | B. Braun Medical, Inc. |
| NDA 19-025 | Isolyte P (multi-electrolyte injection) with 5% Dextrose Do. | |
| NDA 19-033 | Bretylium Tosylate Injection | Hospira, Inc. |
| NDA 19-042 | Heparin Sodium in NaCl Injection | B. Braun Medical, Inc. |
| NDA 19-077 | Sterile Water for Injection USP | Do. |
| NDA 19-134 | Heparin Sodium in 5% Dextrose Injection | Do. |
| NDA 19-135 | Heparin Sodium in 0.9% NaCl Injection | Do. |
| NDA 19-243 | Proventil (albuterol sulfate) Inhalation Solution | Schering Corp. |
| NDA 19-471 | Cardizem SR Capsules (diltiazem HCl), 60 mg, 90 mg, 120 mg, and 180 mg | Biovail Laboratories, Inc., c/o Biovail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807-0980 |
| NDA 19-478 | Adalat (nifedipine) Capsules | Bayer Pharmaceuticals Corp., 400 Morgan Lane, West Haven, CT 06516-4175 |
| NDA 19-604 | Volmax (albuterol sulfate) Extended- Release Tablets | Muro Pharmaceuticals, Inc., 890 East St., Tewksbury, MA 01876-1496 |
| NDA 19-616 | Penetrex (enoxacin) Tablets | Aventis Pharmaceuticals, Inc. |
| NDA 19-698 | Toradol (ketorolac tromethamine) Injection | Roche Palo Alto, LLC, c/o Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110 |
| NDA 19-817 | Persantine (dipyridamole) Injection | Boehringer Ingleheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 |
| NDA 19-978 | Bupivacaine HCl Injection USP | Hospira, Inc. |
| NDA 20-542 | Dopamine HCl in 5% Dextrose Injection | Do. |
| NDA 20-677 | Zagam (sparfloxacin) Tablets, 200 mg | Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504-4310 |
| NDA 20-755 | Caverject (alprostadil) Injection | Pfizer, Inc., 7000 Portage Rd., Kalamazoo, MI 49001 |
| NDA 20-942 | Versed (midazolam HCl) Syrup, 2 mg/mL | Hoffman-La Roche, Inc. |
| NDA 20-997 | Chirocaine (levobupivacaine HCl) Injection | Purdue Pharma L.P., One Stamford Forum, Stamford, CT 06901-3431 |
| NDA 50-010 | Ilosone (erythromycin estolate oral suspension) Liquid | Eli Lilly Co. |
| NDA 50-011 | Pathocil (dicloxacillin sodium) Capsules | Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 50-199 | Unipen (nafcillin sodium) Powder for Oral Solution | Do. |
| NDA 50-271 | Achromycin (tetracycline HCl) Powder for Reconstitution | Lederle, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 50-320 | Unipen (nafcillin sodium) Injection | Wyeth Pharmaceuticals |
| NDA 50-365 | Ilosone (erythromycin estolate USP) Pulvules | Eli Lilly Co. |
| NDA 50-369 | Ilotycin (erythromycin) Tablets | Do. |
| NDA 50-426 | Ilosone (erythromycin estolate USP) Tablets | Do. |
| NDA 50-427 | Minocin (minocycline HCl) Diagnostic Susceptibility Powder | Lederle, c/o Wyeth Pharmaceuticals |
| NDA 50-437 | Garamycin (gentamicin sulfate) Injection, 10 mg/mL | Schering Corp. |
| NDA 50-462 | Unipen (nafcillin sodium) Tablets | Wyeth Pharmaceuticals |
| NDA 50-505 | Garamycin (gentamicin sulfate) Injection, 2 mg/mL | Schering Corp. |
| NDA 50-549 | Mezlin (mezlocillin sodium monohydrate) Sterile Powder for Injection | Bayer Pharmaceuticals Corp. |
| ANDA 60-134 | Ledercillin VK (penicillin V potassium) Tablets, 250 mg and 500 mg | Lederle Laboratories, Pearl River, NY 10965 |
| ANDA 60-136 | Ledercillin VK (penicillin V potassium) for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL | Do. |
| ANDA 60-413 | Penicillin G Potassium Tablets | Wyeth Laboratories |
| ANDA 60-431 | Ilosone (erythromycin estolate USP) Chewable Tablets | Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 |
| ANDA 60-559 | Ilosone (erythromycin estolate) Oral Suspension Liquid | Do. |
| ANDA 60-625 | Omnipen (ampicillin for oral suspension USP) for Oral Suspension | Wyeth Laboratories |
| ANDA 60-626 | Omnipen-N (ampicillin sodium) Injection, 125 mg, 250 mg, 500 mg, 1 gram (g), and 2 g/vial | Do. |
| ANDA 61-655 | Kantrex (kanamycin sulfate) Injection | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 61-675 | Wyamycin S (erythromycin stearate tablets USP), 250 mg and 500 mg | Wyeth Laboratories |
| ANDA 61-685 | Tetracycline HCl Capsules USP, 250 mg and 500 mg | Do. |
| ANDA 61-769 | Cephapirin for Injection USP | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 61-893 | Ilosone (erythromycin estolate USP) for Oral Suspension | Dista, c/o Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 |
| ANDA 61-894 | Ilosone (erythromycin estolate) Oral Suspension | Do. |
| ANDA 61-895 | Ilosone (erythromycin estolate USP) Chewable Tablets | Do. |
| ANDA 61-896 | Ilosone (erythromycin estolate USP) Tablets | Do. |
| ANDA 61-897 | Ilosone (erythromycin estolate USP) Pulvules | Do. |
| ANDA 61-910 | Ilotycin (erythromycin) Enteric Coated Tablets | Do. |
| ANDA 62-123 | Wyamycin E (erythromycin ethylsuccinate) Oral Suspension, 200 mg/5 mL and 400 mg/5 mL | Wyeth Laboratories |
| ANDA 62-131 | Wymox (amoxicillin) for Oral Suspension | Do. |
| ANDA 62-501 | Gentacidin Ophthalmic Ointment (gentamicin sulfate ophthalmic ointment USP) 0.3% | Novartis Ophthalmics, Inc., 11695 John Creek Pkwy., Duluth, GA 30097-1523 |
| ANDA 62-544 | Dexacidin (neomycin sulfate, polymyxin B sulfate, and dexamethasone) Ophthalmic Suspension | Novartis Pharmaceuticals Corp., One Health Plaza, Building 105 Eisenhower, East Hanover, NJ 07936 |
| ANDA 62-566 | Dexacidin (neomycin sulfate, polymyxin B sulfate, and dexamethasone) Ophthalmic Ointment | Novartis Ophthalmics, Inc. |
| ANDA 62-717 | Unipen (nafcillin sodium) Injection, 500-mg, 1-g, and 2-g vials | Wyeth Laboratories |
| ANDA 62-718 | Omnipen-N (ampicillin sodium) Injection, 125-mg, 250-mg, 500-mg, 1-g, and 2-g vials | Do. |
| ANDA 62-726 | Kenamycin Sulfate Capsules USP, 500 mg | Apothecon, c/o Bristol-Myers Squibb Co. |
| ANDA 62-986 | Cephalexin For Oral Suspension USP, 125 mg/5 mL | Do. |
| ANDA 63-107 | Emgel (erythromycin) Topical Gel, 2% | GlalxoSmithKline Consumer Healthcare, L.P., 1500 Littleton Rd., Parsippany, NJ 07054-3884 |
| ANDA 71-159 | Nitro-Bid (nitroglycerin) Injection, 10 mg/mL | Aventis Pharmaceuticals, Inc. |
| ANDA 74-194 | Loperamide HCl Tablets, 2 mg | L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010 |
| ANDA 74-539 | Tamoxifen Citrate Tablets USP, 10 mg | Pharmachemie B.V., c/o Teva Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454-1090 |
| ANDA 75-114 | Acyclovir Injection, 50 mg/mL | Abbott Laboratories |
| ANDA 75-583 | Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg | Apothecon Inc., c/o Bristol-Myers Squibb Co. |
| ANDA 75-729 | Famotidine Injection, 0.4 mg/mL | Abbott Laboratories |
| ANDA 76-214 | Sotalol HCl Tablets, 80 mg, 120 mg, and 160 mg | TorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069 |
| ANDA 83-823 | Nicolar (niacin) Tablets, 500 mg | Aventis Pharmaceuticals, Inc. |
| ANDA 83-892 | Selenium Sulfide Lotion USP | Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623 |
| ANDA 84-476 | Domeboro (acetic acid, glacial and aluminum acetate) SolutionBayer Pharmaceuticals Corp. | |
| ANDA 85-113 | Chlordiazepoxide HCl Capsules USP, 10 mg | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 |
| ANDA 85-187 | Slo-Phyllin (theophylline) Syrup, 80 mg/15 mL | Aventis Pharmaceuticals, Inc. |
| ANDA 85-202 | Slo-Phyllin (theophylline) Tablets, 100 mg | Do. |
| ANDA 85-204 | Slo-Phyllin (theophylline) Tablets, 200 mg | Do. |
| ANDA 86-126 | Nitrong SR (nitroglycerin) Tablets, 6.5 mg | Do. |
| ANDA 86-137 | Nitrong (nitroglycerin) Ointment, 2% | Do. |
| ANDA 86-138 | Nitrong (nitroglycerin) Tablets, 2.6 mg | Do. |
| ANDA 86-681 | Acetaminophen and Codeine Phospate Tablets USP, 300 mg/30 mg | Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207 |
| ANDA 87-715 | Nitrong SR (nitroglycerin) Tablets, 9 mg | Do. |
| ANDA 87-892 | Slo-Bid (theophylline) Capsules, 100 mg | Aventis Pharmaceuticals, Inc. |
| ANDA 87-893 | Slo-Bid (theophylline) Capsules, 200 mg | Do. |
| ANDA 87-894 | Slo-Bid (theophylline) Capsules, 300 mg | Do. |
| ANDA 88-082 | Hydrocortisone USP, Micronized Powder (Nonsterile) | Paddock Laboratories, Inc., 3940 Quebec Ave. South, Minneapolis, MN 55427 |
| ANDA 88-269 | Slo-Bid (theophylline) Capsules, 50 mg | Aventis Pharmaceuticals, Inc. |
| ANDA 88-782 | NTS 5 (nitroglycerin) Transdermal Systems | Hercon Laboratories Corp., 101 Sinking Springs Lake, P.O. Box 467, Emigsville, PA 17318 |
| ANDA 88-783 | NTS 15 (nitroglycerin) Transdermal Systems | Do. |
| ANDA 88-791 | Vasocidin (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment | Novartis Ophthalmics, Inc. |
| ANDA 89-047 | Sulf-15 (sulfacetamide sodium ophthalmic solution USP), 15% | Do. |
| ANDA 89-516 | NTS 10 (nitroglycerin) Transdermal Systems | Hercon Laboratories Corp. |
| ANDA 89-539 | Slo-Bid (theophylline) Capsules, 75 mg | Aventis Pharmaceuticals, Inc. |
| ANDA 89-540 | Slo-Bid (theophylline) Capsules, 125 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 April 4, 2005.
Dated: January 31, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-4158 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S