AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 103 new drug applications (NDAs) and 35 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 March 13, 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 7-335 | Pronestyl (procainamide hydrochloride (HCl)) Capsules and Injection | Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000 |
| NDA 7-935 | Phenergan (promethazine HCl) Tablets | Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 9-193 | Cogentin (benztropine mesylate) Tablets | Merck & Co., Inc., Sunneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486 |
| NDA 9-986 | Deltasone (prednisone) Tablets | Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York, NY 10017 |
| NDA 10-374 | Medihaler-Epi (epinephrine bitartrate) | 3M Pharmaceuticals, 3M Center, Bldg. 0275-05-W-12, St. Paul, MN 55144-1000 |
| NDA 10-375 | Medihaler-ISO (isoproterenol) | Do. |
| NDA 10-598 | Bendectin (doxylamine succinate and pyridoxine HCl) Tablets | Sanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807-0977 |
| NDA 10-796 | Harmonyl (deserpidine) Tablets | Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60064-6154 |
| NDA 10-800 | Tralgon (acetaminophen) Elixir | Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000 |
| NDA 10-927 | Phosphotope (sodium phosphates solution USP) Oral Solution | Bracco Diagnostics, P.O. Box 5225, Princeton, NJ 08543-5225 |
| NDA 10-928 | Aureotope (gold injection) | Do. |
| NDA 11-161 | Aristocort (triamcinolone) Tablets | Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2537 |
| NDA 11-467 | Trancopal (chlormezanone) Tablets | Sanofi-Aventis |
| NDA 11-721 | Neptazane (methazolamide) Tablets | Lederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299 |
| NDA 11-751 | Prolixin (fluphenazine HCl) Injection and Tablets | Apothecon, c/o Bristol-Myers Squibb Co. |
| NDA 11-832 | Vasodilan (isoxsuprine HCl) | Do. |
| NDA 12-097 | Kenalog in Orabase (triamcinolone acetonide dental paste USP) | Do. |
| NDA 12-164 | Naturetin (bendroflumethiazide USP), 2.5 milligrams (mg), 5 mg, and 10 mg | Do. |
| NDA 12-515 | Kenacort (tramcinolone diacetate) Syrup | Bristol-Meyers Squibb Co. |
| NDA 13-296 | Duo-Medihaler (phenyleprine bitartrate and isoproterenol HCl) | 3M Pharmaceuticals |
| NDA 13-601 | Mucomyst (acetylcysteine solution USP) | Apothecon, c/o Bristol-Myers Squibb Co. |
| NDA 14-715 | Triavil (perphenazine and amitriptyline HCl) Tablets | New River Pharmaceuticals, Inc., 2200 Kraft Dr., suite 2050, Blacksburg, VA 24060 |
| NDA 15-419 | Hipputope (iodohippurate sodium I-131 injection USP) | Bracco Diagnostics |
| NDA 16-033 | Vontrol (diphenidol HCl) Tablets, 25 mg | GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709 |
| NDA 16-090 | Rubratope-60 (cyanocobalamin CO-60) | Bracco Diagnostics |
| NDA 16-224 | Robengatope (rose bengal sodium I-131 injection USP) | Do. |
| NDA 16-727 | Prolixin Decanoate (fluphenazine decanoate) Injection | Bristol-Myers Squibb Co. |
| NDA 16-783 | Vascoray (iothalamate meglumine, 52% and iothalamate sodium, 26% injection) | Tyco Healthcare/Mallinckrodt Inc., P.O. Box 5840, St. Louis, MO 63134-0840 |
| NDA 16-906 | Technetope II (technetium Tc-99m sodium pertechnetate sterile generator | Bracco Diagnostics |
| NDA 16-923 | Tesuloid (technetium Tc-99m sulfur colloid kit) | Do. |
| NDA 16-929 | FUDR (floxuridine) Injection, 500 mg/5 milliliters (mL) | Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046 |
| NDA 16-996 | Hyperstat (diazoxide) Injection | Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 |
| NDA 17-024 | Strotope (strontium nitrate Sr-85) Injection | Bracco Diagnostics |
| NDA 17-045 | Renotec (technetium Tc-99m ferpenetate kit) | Do. |
| NDA 17-047 | Sethotope (selenomethionine Se-75) Injection | Do. |
| NDA 17-269 | Chlormerodrin Hg-197 Injection | Do. |
| NDA 17-339 | Minitec (technetium Tc-99m sodium pertechnetate generator) | Do. |
| NDA 17-371 | Pronestyl (procainamide HCl) Tablets | Apothecon, c/o Bristol-Myers Squibb Co. |
| NDA 17-395 | Intropin (dopamine HCl) Injection, 40 mg/mL, 80 mg/mL, and 160 mg/mL | Hospira, Inc. |
| NDA 17-598 | Septra (trimethoprim and sulfamethoxazole) Oral Suspension | Monarch Pharmaceutcals, Inc., 501 5th St., Bristol, TN 37620 |
| NDA 17-685 | Conray 325 (iothalamate sodium) | Mallinckrodt Inc., 675 McDonnell Blvd., P.O. Box 5840, St. Louis, MO 63134 |
| NDA 17-787 | Radionuclide-Labeled (I-125) Fibrinogen Sensor | Abbott Laboratories |
| NDA 17-834 | Albumotope-LS (albumin aggregated iodinated I-131-serum) | Bracco Diagnostics |
| NDA 17-902 | Renovue-65 (iodamide meglumine) Injection, 65% | Do. |
| NDA 17-903 | Renovue-Dip (iodamide meglumine) Injection | Do. |
| NDA 17-931 | Iletin I (insulin pork) | Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 |
| NDA 17-932 | Protamine Zinc and Iletin I (insulin suspension protamine zinc beef/pork) | Do. |
| NDA 17-935 | Ultralente Iletin I (insulin zinc suspension extended beef/pork) | Do. |
| NDA 17-936 | NPH Iletin I (insulin suspension isophane beef/pork) | Do. |
| NDA 17-943 | Proloprin (trimethoprim) Tablets, 100 mg and 200 mg | Monarch Pharmaceuticals, Inc. |
| NDA 17-970 | Nolvadex (tamoxifen citrate) Tablets | AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355 |
| NDA 17-979 | Heparin Sodium Injection USP | Abraxis Pharmaceutical Products, Riverway One, 6133 North River Rd., suite 500, Rosemont, IL 60018 |
| NDA 18-017 | Blocadren (timolol maleate) Tablets | Merck & Co., Inc., UG2C-50, P.O. Box 1000, North Wales, PA 19454-1099 |
| NDA 18-061 | Timolide (timolol maleate and hydrochorothiazide) Tablets, 10 mg/25mg | Do. |
| NDA 18-076 | Cholovue (iodoxamate meglumine) Injection, 40.3% | Bracco Diagnostics |
| NDA 18-077 | Cholovue (iodoxamate meglumine) for Infusion | Do. |
| NDA 18-116 | Cyclocort (amcinonide) Cream, 0.1% | Astellas Pharma US, Inc. |
| NDA 18-211 | Ditropan (oxybutynin chloride) Syrup, 5 mg | Ortho-McNeil-Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, P.O. Box 3000, Raritan, NJ 08869-0602 |
| NDA 18-344 | Iletin II (insulin purified pork) | Eli Lilly & Co. |
| NDA 18-345 | NPH Iletin II (insulin suspension isophane purified pork) | Do. |
| NDA 18-346 | Protamine, Zinc, and Iletin II (insulin suspension protamine zinc purified pork) | Do. |
| NDA 18-347 | Lente Iletin II (insulin zinc suspension purified pork) | Do. |
| NDA 18-354 | Ortho-Novum 10/11-21 and 10/11-28 (norethindrone and ethinyl estradiol) Tablets | Ortho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, 920 Rt. 202 South, P.O. Box 300, Raritan, NJ 08869 |
| NDA 18-452 | Septra (sulfamethoxazole and trimethorprim) Injection | Monarch Pharmaceuticals, Inc. |
| NDA 18-476 | Protamine, Zinc, and Iletin II (insulin suspension protamine zinc purified beef) | Eli Lilly & Co. |
| NDA 18-477 | Lente Iletin II (insulin zinc suspension purified beef) | Do. |
| NDA 18-478 | Regular Iletin II (insulin purified beef) | Do. |
| NDA 18-479 | NPH Iletin II (insulin suspension isophane purified beef) | Do. |
| NDA 18-498 | Cyclocort (amcinonide) Ointment, 0.1% | Astellas Pharma US, Inc. |
| NDA 18-537 | Tridil (nitroglycerin) Injection | Hospira, Inc. |
| NDA 18-831 | Tracrium (atracurium besylate) Injection | Hospira, Inc. |
| NDA 18-873 | Mexitil (mexiletine HCl) Capsules, 150 mg, 200 mg, and 250 mg | Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 |
| NDA 18-922 | Lodine (etodolac) Capsules and Tablets | Wyeth Pharmaceuticals, Inc. |
| NDA 19-085 | Atrovent (ipratropium bromide) Aerosol | Boehringer Ingelheim Pharmaceuticals, Inc. |
| NDA 19-166 | Regular Insulin (insulin zinc suspension beef) Injection | Eli Lilly & Co. |
| NDA 19-167 | NPH Insulin Beef (insulin zinc suspension beef) | Do. |
| NDA 19-529 | Humulin BR (insulin recombinant human) | Do. |
| NDA 19-729 | Cyclocort (amcinonide) Lotion, 0.1% | Astellas Pharma US, Inc. |
| NDA 19-816 | Oruvail (ketoprofen) Extended-Release Capsules | Wyeth Pharmaceuticals, Inc. |
| NDA 19-890 | Stadol (butorphanol tartrate) Nasal Spray | Bristol-Myers Squibb Co. |
| NDA 19-965 | Novolin L (insulin zinc suspension recombinant human) | Novo Nordisk, Inc., 100 College Road West, Princeton, NJ 08540 |
| NDA 20-152 | Serzone (nefazodone HCl) Tablets | Bristol-Myers Squibb Co. |
| NDA 20-219 | Livostin (levocabastine HCl) Ophthalmic Suspension, 0.05% | Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080 |
| NDA 20-225 | Indur (isosorbide mononitrate) Extended-Release Tablets, 30 mg, 60 mg, and 120 mg | Schering Corp. |
| NDA 20-326 | Neutrexin (trimetrexate glucuronate) Injection, 25 mg and 200 mg vials | MedImmune Oncology, Inc., One MedImmune Way, Gaithersburg, MD 20878 |
| NDA 20-377 | Cordarone (amiodarone HCl), Injection, 50 mg/mL | Wyeth Pharmaceuticals, Inc. |
| NDA 20-429 | Orudis KT (ketoprofen) Tablets, 12.5 mg | Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940 |
| NDA 20-584 | Lodine XL (etodolac) Extended-Release Tablets | Wyeth Pharmaceuticals, Inc. |
| NDA 20-698 | MiraLax (polyethylene glycol 3350) Powder for Solution | Braintree Laboratories, Inc., 60 Columbian Street West, P.O. Box 850929, Braintree, MA 02185-0929 |
| NDA 20-784 | Nasacort HFA (triamcinolone acetonide) Nasal Spray | Sanofi-Aventis |
| NDA 20-974 | Prozac (fluoxetine HCl) Tablets | Eli Lilly & Co. |
| NDA 21-028 | Velosulin BR (insulin recombinant injection) | Novo Nordisk, Inc. |
| NDA 21-369 | Codeprex (codeine polistirex and chlorpheniramine polistirex) Extended-Release Suspension | UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080 |
| NDA 21-387 | Pravigard Pak (copackaged) (pravastatin sodium and aspirin) Tablets | Bristol-Meyers Squibb Co. |
| ANDA 40-305 | Meperidien HCl Injection USP, 10 mg/mL | Hospira, Inc. |
| NDA 50-155 | Chloromycetin Sodium Succinate (chloramphenicol sodium succinate for injection USP) | Parkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620 |
| NDA 50-205 | Chloromycetin (chloramphenicol) Otitic Solution | Do. |
| NDA 50-285 | Mycifradin (neomycin sulfate) Oral Suspension | Pharmacia & Upjohn Co., c/o Pfizer, Inc. |
| NDA 50-339 | Albamycin (novobiocin sodium) Capsules | Do. |
| NDA 50-435 | Geocillin (carbenicillin indanyl sodium) Tablets, 382 mg | Pfizer, Inc., 235 East 42d St., New York, NY 10017 |
| NDA 50-504 | Mandol (cefamandole nafate) Injection | Eli Lilly & Co. |
| NDA 50-589 | Cefizox (ceftizoxime sodium) | Astellas Pharma US, Inc. |
| NDA 50-621 | Suprax (cefixime) Tablets, 200 mg and 400 mg | Lederle Laboratories, c/o Wyeth Pharmaceuticals, Inc. |
| NDA 50-622 | Suprax (cefixime) Powder for Suspension | Do. |
| ANDA 60-591 | Chloromycetin (chloramphenicol capsules USP), 50 mg, 100 mg, and 250 mg | Parkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc. |
| ANDA 61-922 | Vidarabine Monohydrate Micronized Powder, Sterile | Do. |
| ANDA 62-655 | Tazidime (ceftazidime for injection USP) | Eli Lilly & Co. |
| ANDA 63-350 | Amikacin Sulfate Injection USP, 50 mg base/mL and 250 mg base/mL | Hospira, Inc. |
| ANDA 70-847 | Metoclopramide Injection USP, 5 mg base/mL | Hospira, Inc. |
| ANDA 71-291 | Metoclopramide Injection USP, 5 mg base/mL | Do. |
| ANDA 71-364 | Acetylcysteine Solution USP | Do. |
| ANDA 71-365 | Acetylcysteine Solution USP | Do. |
| ANDA 71-645 | Droperidol Injection USP, 2.5 mg/mL | Do. |
| ANDA 73-272 | Albuterol Inhalation Aerosol | IVAX Pharmaceuticals Ireland, c/o IVAX Pharmaceuticals, Inc., Two University Plaza, suite 220, Hackensack, NJ 07601 |
| ANDA 74-966 | Fluphenazine Decanoate Injection, 25 mg/mL | Hospira, Inc. |
| ANDA 75-106 | Diltiazem HCl Injection, 5 mg/mL | Do. |
| ANDA 75-242 | Labetalol HCL Injection, 5 mg/mL | Do. |
| ANDA 75-342 | Butorphanol Tartrate Injection USP, 1 mg/mL and 2mg/mL | Do. |
| ANDA 75-396 | Midazolam HCl Injection | Do. |
| ANDA 75-484 | Midazolam HCl Injection, 5 mg base/mL | Do. |
| ANDA 75-571 | Enalaprilat Injection, 1.25 mg/mL | Do. |
| ANDA 75-669 | Famotidine Injection, 10 mg/mL | Do. |
| ANDA 75-705 | Famotidine Injection, 10 mg/mL | Do. |
| ANDA 75-816 | Calcitriol Injection | Do. |
| ANDA 75-830 | Milrinone Lactate Injection, 1 mg base/mL | Do. |
| ANDA 75-108 | Amiodarone HCl Injection, 50 mg/mL | Do. |
| ANDA 76-233 | Paclitaxel Injection | Do. |
| ANDA 76-473 | Carboplatin for Injection USP | Do. |
| ANDA 76-978 | Ondansetron HCl and Dextrose Injection | Do. |
| ANDA 77-362 | Amlodipine Besylate Tablets | King and Spalding, U.S. Agent for Genpharm Inc., 1700 Pennsylvania Ave., NW., Washington, DC 20006-4706 |
| ANDA 77-925 | Meloxicam Tablets, 7.5 mg and 15 mg | Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228 |
| ANDA 85-153 | Alkergot (ergoloid mesylates) Sublingual Tablets, 0.5 mg | Sandoz, Inc., 227-15 North Conduit Ave., Laurelton, NY 11413 |
| ANDA 85-916 | Diethylpropion HCl Tablets, 25 mg | Do. |
| ANDA 86-172 | Meclizine HCl Tablets, 12.5 mg | Do. |
| ANDA 86-174 | Meclizine HCl Tablets, 25 mg | Do. |
| ANDA 86-184 | Sulfasalazine Tablets, 500 mg | Do. |
| ANDA 87-417 | Alkergot (ergoloid mesylates) Sublingual Tablets, 1 mg | Do. |
| ANDA 89-565 | Vinblastine Sulfate Injection, 10 mg/vial | 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 March 13, 2009.
Dated: January 12, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-2901 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S