Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications, 6896-6901 [E9-2901]

Download as PDF 6896 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices more accurately describe the information collection content. Section 2(c) of The Medical Device User Fee Stabilization Act of 2005 (Public Law 109–43) amends section 502(u) of the act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Under the amended provision, if the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the device or attachment to the device. If the original SUD does not prominently and conspicuously bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse, may identify itself using a detachable label that is intended to be affixed to the patient record. The requirements of section 502(u) of the act impose a minimal burden on industry. This section of the act only requires the manufacturer, packer, or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied. From its registration and premarket submission database, FDA estimates that there are 10 establishments that distribute approximately 1,000 reprocessed SUDs. Each response is anticipated to take 0.1 hours resulting in a total burden to industry of 100 hours. In the Federal Register of November 17, 2008 (73 FR 67873), FDA published a 60-day notice requesting public comment on the information collection provisions. The agency received one comment in support of the collection of information stating that it is necessary to help reprocessors of SUDs comply with section 502(u) of the act. The comment further stated that the estimated reporting burden did not appear excessive. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Section of the Act 502(u) 1There 10 Total Annual Responses 100 Hours per Response 1,000 Total Hours .1 100 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 26, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–2902 Filed 2–10–09; 8:45 am] ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0026] Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications Food and Drug Administration, HHS. Application No. Silver Spring, MD 20993–0002, 301– 796–3601. 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. BILLING CODE 4160–01–S AGENCY: Annual Frequency per Response DATES: 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. SUPPLEMENTARY INFORMATION: 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, Drug Applicant 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 mstockstill on PROD1PC66 with NOTICES NDA 7–335 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 VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\11FEN1.SGM 11FEN1 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices Application No. Drug 6897 Applicant 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 mstockstill on PROD1PC66 with NOTICES NDA 10–796 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. VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\11FEN1.SGM 11FEN1 6898 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices Application No. Drug Applicant 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 I131-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 mstockstill on PROD1PC66 with NOTICES NDA 17–371 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. VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\11FEN1.SGM 11FEN1 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices Application No. Drug 6899 Applicant 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 mstockstill on PROD1PC66 with NOTICES NDA 18–476 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. VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\11FEN1.SGM 11FEN1 6900 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices Application No. Drug Applicant 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 mstockstill on PROD1PC66 with NOTICES ANDA 40–305 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. VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\11FEN1.SGM 11FEN1 Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices Application No. Drug 6901 Applicant 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA2008E0091; Docket No. FDA2008E0099; Docket No. FDA2008E0204] Determination of Regulatory Review Period for Purposes of Patent Extension; MACROPLASTIQUE IMPLANTS AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for MACROPLASTIQUE IMPLANTS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the VerDate Nov<24>2008 17:58 Feb 10, 2009 Jkt 217001 extension of patents which claim that medical device. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device MACROPLASTIQUE IMPLANTS. MACROPLASTIQUE IMPLANTS are indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for MACROPLASTIQUE IMPLANTS (U.S. Patent Nos. 5,258,028;. 5,336,263; and 5,571,182) from Uroplasty, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining these patents’ eligibilities for patent term restoration. In a letter dated May 6, 2008, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of MACROPLASTIQUE IMPLANTS represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for MACROPLASTIQUE IMPLANTS is 2,651 days. Of this time, 1,973 days occurred during the testing phase of the E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6896-6901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2901]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0026]


Apothecon et al.; Withdrawal of Approval of 103 New Drug 
Applications and 35 Abbreviated New Drug Applications

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               Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box
                         hydrochloride (HCl)) Capsules and     4000, Princeton, NJ 08543-4000
                         Injection
----------------------------------------------------------------------------------------------------------------
NDA 7-935               Phenergan (promethazine HCl) Tablets  Wyeth Pharmaceuticals, Inc., P.O. Box 8299,
                                                               Philadelphia, PA 19101-8299
----------------------------------------------------------------------------------------------------------------
NDA 9-193               Cogentin (benztropine mesylate)       Merck & Co., Inc., Sunneytown Pike, P.O. Box 4,
                         Tablets                               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            3M Pharmaceuticals, 3M Center, Bldg. 0275-05-W-12,
                         bitartrate)                           St. Paul, MN 55144-1000
----------------------------------------------------------------------------------------------------------------
NDA 10-375              Medihaler-ISO (isoproterenol)         Do.
----------------------------------------------------------------------------------------------------------------
NDA 10-598              Bendectin (doxylamine succinate and   Sanofi-Aventis, 300 Somerset Corporate Blvd.,
                         pyridoxine HCl) Tablets               Bridgewater, NJ 08807-0977
----------------------------------------------------------------------------------------------------------------

[[Page 6897]]

 
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        Bracco Diagnostics, P.O. Box 5225, Princeton, NJ
                         solution USP) Oral Solution           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)           Apothecon, c/o Bristol-Myers Squibb Co.
                         Injection and Tablets
----------------------------------------------------------------------------------------------------------------
NDA 11-832              Vasodilan (isoxsuprine HCl)           Do.
----------------------------------------------------------------------------------------------------------------
NDA 12-097              Kenalog in Orabase (triamcinolone     Do.
                         acetonide dental paste USP)
----------------------------------------------------------------------------------------------------------------
NDA 12-164              Naturetin (bendroflumethiazide USP),  Do.
                         2.5 milligrams (mg), 5 mg, and 10
                         mg
----------------------------------------------------------------------------------------------------------------
NDA 12-515              Kenacort (tramcinolone diacetate)     Bristol-Meyers Squibb Co.
                         Syrup
----------------------------------------------------------------------------------------------------------------
NDA 13-296              Duo-Medihaler (phenyleprine           3M Pharmaceuticals
                         bitartrate and isoproterenol HCl)
----------------------------------------------------------------------------------------------------------------
NDA 13-601              Mucomyst (acetylcysteine solution     Apothecon, c/o Bristol-Myers Squibb Co.
                         USP)
----------------------------------------------------------------------------------------------------------------
NDA 14-715              Triavil (perphenazine and             New River Pharmaceuticals, Inc., 2200 Kraft Dr.,
                         amitriptyline HCl) Tablets            suite 2050, Blacksburg, VA 24060
----------------------------------------------------------------------------------------------------------------
NDA 15-419              Hipputope (iodohippurate sodium I-    Bracco Diagnostics
                         131 injection USP)
----------------------------------------------------------------------------------------------------------------
NDA 16-033              Vontrol (diphenidol HCl) Tablets, 25  GlaxoSmithKline, Five Moore Dr., P.O. Box 13398,
                         mg                                    Research Triangle Park, NC 27709
----------------------------------------------------------------------------------------------------------------
NDA 16-090              Rubratope-60 (cyanocobalamin CO-60)   Bracco Diagnostics
----------------------------------------------------------------------------------------------------------------
NDA 16-224              Robengatope (rose bengal sodium I-    Do.
                         131 injection USP)
----------------------------------------------------------------------------------------------------------------
NDA 16-727              Prolixin Decanoate (fluphenazine      Bristol-Myers Squibb Co.
                         decanoate) Injection
----------------------------------------------------------------------------------------------------------------
NDA 16-783              Vascoray (iothalamate meglumine, 52%  Tyco Healthcare/Mallinckrodt Inc., P.O. Box 5840,
                         and iothalamate sodium, 26%           St. Louis, MO 63134-0840
                         injection)
----------------------------------------------------------------------------------------------------------------
NDA 16-906              Technetope II (technetium Tc-99m      Bracco Diagnostics
                         sodium pertechnetate sterile
                         generator
----------------------------------------------------------------------------------------------------------------
NDA 16-923              Tesuloid (technetium Tc-99m sulfur    Do.
                         colloid kit)
----------------------------------------------------------------------------------------------------------------
NDA 16-929              FUDR (floxuridine) Injection, 500 mg/ Hospira, Inc., 275 North Field Dr., Lake Forest,
                         5 milliliters (mL)                    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)    Bracco Diagnostics
                         Injection
----------------------------------------------------------------------------------------------------------------
NDA 17-045              Renotec (technetium Tc-99m            Do.
                         ferpenetate kit)
----------------------------------------------------------------------------------------------------------------
NDA 17-047              Sethotope (selenomethionine Se-75)    Do.
                         Injection
----------------------------------------------------------------------------------------------------------------
NDA 17-269              Chlormerodrin Hg-197 Injection        Do.
----------------------------------------------------------------------------------------------------------------
NDA 17-339              Minitec (technetium Tc-99m sodium     Do.
                         pertechnetate generator)
----------------------------------------------------------------------------------------------------------------

[[Page 6898]]

 
NDA 17-371              Pronestyl (procainamide HCl) Tablets  Apothecon, c/o Bristol-Myers Squibb Co.
----------------------------------------------------------------------------------------------------------------
NDA 17-395              Intropin (dopamine HCl) Injection,    Hospira, Inc.
                         40 mg/mL, 80 mg/mL, and 160 mg/mL
----------------------------------------------------------------------------------------------------------------
NDA 17-598              Septra (trimethoprim and              Monarch Pharmaceutcals, Inc., 501 5th St.,
                         sulfamethoxazole) Oral Suspension     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)          Abbott Laboratories
                         Fibrinogen Sensor
----------------------------------------------------------------------------------------------------------------
NDA 17-834              Albumotope-LS (albumin aggregated     Bracco Diagnostics
                         iodinated I-131-serum)
----------------------------------------------------------------------------------------------------------------
NDA 17-902              Renovue-65 (iodamide meglumine)       Do.
                         Injection, 65%
----------------------------------------------------------------------------------------------------------------
NDA 17-903              Renovue-Dip (iodamide meglumine)      Do.
                         Injection
----------------------------------------------------------------------------------------------------------------
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  Do.
                         suspension protamine zinc beef/
                         pork)
----------------------------------------------------------------------------------------------------------------
NDA 17-935              Ultralente Iletin I (insulin zinc     Do.
                         suspension extended beef/pork)
----------------------------------------------------------------------------------------------------------------
NDA 17-936              NPH Iletin I (insulin suspension      Do.
                         isophane beef/pork)
----------------------------------------------------------------------------------------------------------------
NDA 17-943              Proloprin (trimethoprim) Tablets,     Monarch Pharmaceuticals, Inc.
                         100 mg and 200 mg
----------------------------------------------------------------------------------------------------------------
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         Do.
                         hydrochorothiazide) Tablets, 10 mg/
                         25mg
----------------------------------------------------------------------------------------------------------------
NDA 18-076              Cholovue (iodoxamate meglumine)       Bracco Diagnostics
                         Injection, 40.3%
----------------------------------------------------------------------------------------------------------------
NDA 18-077              Cholovue (iodoxamate meglumine) for   Do.
                         Infusion
----------------------------------------------------------------------------------------------------------------
NDA 18-116              Cyclocort (amcinonide) Cream, 0.1%    Astellas Pharma US, Inc.
----------------------------------------------------------------------------------------------------------------
NDA 18-211              Ditropan (oxybutynin chloride)        Ortho-McNeil-Janssen Pharmaceuticals, Inc., 1000
                         Syrup, 5 mg                           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     Do.
                         isophane purified pork)
----------------------------------------------------------------------------------------------------------------
NDA 18-346              Protamine, Zinc, and Iletin II        Do.
                         (insulin suspension protamine zinc
                         purified pork)
----------------------------------------------------------------------------------------------------------------
NDA 18-347              Lente Iletin II (insulin zinc         Do.
                         suspension purified pork)
----------------------------------------------------------------------------------------------------------------
NDA 18-354              Ortho-Novum 10/11-21 and 10/11-28     Ortho-McNeil Pharmaceutical, Inc., c/o Johnson &
                         (norethindrone and ethinyl            Johnson Pharmaceutical Research & Development,
                         estradiol) Tablets                    LLC, 920 Rt. 202 South, P.O. Box 300, Raritan, NJ
                                                               08869
----------------------------------------------------------------------------------------------------------------
NDA 18-452              Septra (sulfamethoxazole and          Monarch Pharmaceuticals, Inc.
                         trimethorprim) Injection
----------------------------------------------------------------------------------------------------------------

[[Page 6899]]

 
NDA 18-476              Protamine, Zinc, and Iletin II        Eli Lilly & Co.
                         (insulin suspension protamine zinc
                         purified beef)
----------------------------------------------------------------------------------------------------------------
NDA 18-477              Lente Iletin II (insulin zinc         Do.
                         suspension purified beef)
----------------------------------------------------------------------------------------------------------------
NDA 18-478              Regular Iletin II (insulin purified   Do.
                         beef)
----------------------------------------------------------------------------------------------------------------
NDA 18-479              NPH Iletin II (insulin suspension     Do.
                         isophane purified beef)
----------------------------------------------------------------------------------------------------------------
NDA 18-498              Cyclocort (amcinonide) Ointment,      Astellas Pharma US, Inc.
                         0.1%
----------------------------------------------------------------------------------------------------------------
NDA 18-537              Tridil (nitroglycerin) Injection      Hospira, Inc.
----------------------------------------------------------------------------------------------------------------
NDA 18-831              Tracrium (atracurium besylate)        Hospira, Inc.
                         Injection
----------------------------------------------------------------------------------------------------------------
NDA 18-873              Mexitil (mexiletine HCl) Capsules,    Boehringer Ingelheim Pharmaceuticals, Inc., 900
                         150 mg, 200 mg, and 250 mg            Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-
                                                               0368
----------------------------------------------------------------------------------------------------------------
NDA 18-922              Lodine (etodolac) Capsules and        Wyeth Pharmaceuticals, Inc.
                         Tablets
----------------------------------------------------------------------------------------------------------------
NDA 19-085              Atrovent (ipratropium bromide)        Boehringer Ingelheim Pharmaceuticals, Inc.
                         Aerosol
----------------------------------------------------------------------------------------------------------------
NDA 19-166              Regular Insulin (insulin zinc         Eli Lilly & Co.
                         suspension beef) Injection
----------------------------------------------------------------------------------------------------------------
NDA 19-167              NPH Insulin Beef (insulin zinc        Do.
                         suspension beef)
----------------------------------------------------------------------------------------------------------------
NDA 19-529              Humulin BR (insulin recombinant       Do.
                         human)
----------------------------------------------------------------------------------------------------------------
NDA 19-729              Cyclocort (amcinonide) Lotion, 0.1%   Astellas Pharma US, Inc.
----------------------------------------------------------------------------------------------------------------
NDA 19-816              Oruvail (ketoprofen) Extended-        Wyeth Pharmaceuticals, Inc.
                         Release Capsules
----------------------------------------------------------------------------------------------------------------
NDA 19-890              Stadol (butorphanol tartrate) Nasal   Bristol-Myers Squibb Co.
                         Spray
----------------------------------------------------------------------------------------------------------------
NDA 19-965              Novolin L (insulin zinc suspension    Novo Nordisk, Inc., 100 College Road West,
                         recombinant human)                    Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
NDA 20-152              Serzone (nefazodone HCl) Tablets      Bristol-Myers Squibb Co.
----------------------------------------------------------------------------------------------------------------
NDA 20-219              Livostin (levocabastine HCl)          Novartis Pharmaceuticals Corp., One Health Plaza,
                         Ophthalmic Suspension, 0.05%          East Hanover, NJ 07936-1080
----------------------------------------------------------------------------------------------------------------
NDA 20-225              Indur (isosorbide mononitrate)        Schering Corp.
                         Extended-Release Tablets, 30 mg, 60
                         mg, and 120 mg
----------------------------------------------------------------------------------------------------------------
NDA 20-326              Neutrexin (trimetrexate glucuronate)  MedImmune Oncology, Inc., One MedImmune Way,
                         Injection, 25 mg and 200 mg vials     Gaithersburg, MD 20878
----------------------------------------------------------------------------------------------------------------
NDA 20-377              Cordarone (amiodarone HCl),           Wyeth Pharmaceuticals, Inc.
                         Injection, 50 mg/mL
----------------------------------------------------------------------------------------------------------------
NDA 20-429              Orudis KT (ketoprofen) Tablets, 12.5  Wyeth Consumer Healthcare, Five Giralda Farms,
                         mg                                    Madison, NJ 07940
----------------------------------------------------------------------------------------------------------------
NDA 20-584              Lodine XL (etodolac) Extended-        Wyeth Pharmaceuticals, Inc.
                         Release Tablets
----------------------------------------------------------------------------------------------------------------
NDA 20-698              MiraLax (polyethylene glycol 3350)    Braintree Laboratories, Inc., 60 Columbian Street
                         Powder for Solution                   West, P.O. Box 850929, Braintree, MA 02185-0929
----------------------------------------------------------------------------------------------------------------
NDA 20-784              Nasacort HFA (triamcinolone           Sanofi-Aventis
                         acetonide) Nasal Spray
----------------------------------------------------------------------------------------------------------------
NDA 20-974              Prozac (fluoxetine HCl) Tablets       Eli Lilly & Co.
----------------------------------------------------------------------------------------------------------------
NDA 21-028              Velosulin BR (insulin recombinant     Novo Nordisk, Inc.
                         injection)
----------------------------------------------------------------------------------------------------------------
NDA 21-369              Codeprex (codeine polistirex and      UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080
                         chlorpheniramine polistirex)
                         Extended-Release Suspension
----------------------------------------------------------------------------------------------------------------
NDA 21-387              Pravigard Pak (copackaged)            Bristol-Meyers Squibb Co.
                         (pravastatin sodium and aspirin)
                         Tablets
----------------------------------------------------------------------------------------------------------------

[[Page 6900]]

 
ANDA 40-305             Meperidien HCl Injection USP, 10 mg/  Hospira, Inc.
                         mL
----------------------------------------------------------------------------------------------------------------
NDA 50-155              Chloromycetin Sodium Succinate        Parkedale Pharmaceuticals, Inc., c/o King
                         (chloramphenicol sodium succinate     Pharmaceuticals, Inc., 501 5th St., Bristol, TN
                         for injection USP)                    37620
----------------------------------------------------------------------------------------------------------------
NDA 50-205              Chloromycetin (chloramphenicol)       Do.
                         Otitic Solution
----------------------------------------------------------------------------------------------------------------
NDA 50-285              Mycifradin (neomycin sulfate) Oral    Pharmacia & Upjohn Co., c/o Pfizer, Inc.
                         Suspension
----------------------------------------------------------------------------------------------------------------
NDA 50-339              Albamycin (novobiocin sodium)         Do.
                         Capsules
----------------------------------------------------------------------------------------------------------------
NDA 50-435              Geocillin (carbenicillin indanyl      Pfizer, Inc., 235 East 42d St., New York, NY 10017
                         sodium) Tablets, 382 mg
----------------------------------------------------------------------------------------------------------------
NDA 50-504              Mandol (cefamandole nafate)           Eli Lilly & Co.
                         Injection
----------------------------------------------------------------------------------------------------------------
NDA 50-589              Cefizox (ceftizoxime sodium)          Astellas Pharma US, Inc.
----------------------------------------------------------------------------------------------------------------
NDA 50-621              Suprax (cefixime) Tablets, 200 mg     Lederle Laboratories, c/o Wyeth Pharmaceuticals,
                         and 400 mg                            Inc.
----------------------------------------------------------------------------------------------------------------
NDA 50-622              Suprax (cefixime) Powder for          Do.
                         Suspension
----------------------------------------------------------------------------------------------------------------
ANDA 60-591             Chloromycetin (chloramphenicol        Parkedale Pharmaceuticals, Inc., c/o King
                         capsules USP), 50 mg, 100 mg, and     Pharmaceuticals, Inc.
                         250 mg
----------------------------------------------------------------------------------------------------------------
ANDA 61-922             Vidarabine Monohydrate Micronized     Do.
                         Powder, Sterile
----------------------------------------------------------------------------------------------------------------
ANDA 62-655             Tazidime (ceftazidime for injection   Eli Lilly & Co.
                         USP)
----------------------------------------------------------------------------------------------------------------
ANDA 63-350             Amikacin Sulfate Injection USP, 50    Hospira, Inc.
                         mg base/mL and 250 mg base/mL
----------------------------------------------------------------------------------------------------------------
ANDA 70-847             Metoclopramide Injection USP, 5 mg    Hospira, Inc.
                         base/mL
----------------------------------------------------------------------------------------------------------------
ANDA 71-291             Metoclopramide Injection USP, 5 mg    Do.
                         base/mL
----------------------------------------------------------------------------------------------------------------
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  Hospira, Inc.
                         mg/mL
----------------------------------------------------------------------------------------------------------------
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,   Do.
                         1 mg/mL and 2mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 75-396             Midazolam HCl Injection               Do.
----------------------------------------------------------------------------------------------------------------
ANDA 75-484             Midazolam HCl Injection, 5 mg base/   Do.
                         mL
----------------------------------------------------------------------------------------------------------------
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     Do.
                         base/mL
----------------------------------------------------------------------------------------------------------------
ANDA 75-108             Amiodarone HCl Injection, 50 mg/mL    Do.
----------------------------------------------------------------------------------------------------------------
ANDA 76-233             Paclitaxel Injection                  Do.
----------------------------------------------------------------------------------------------------------------
ANDA 76-473             Carboplatin for Injection USP         Do.
----------------------------------------------------------------------------------------------------------------

[[Page 6901]]

 
ANDA 76-978             Ondansetron HCl and Dextrose          Do.
                         Injection
----------------------------------------------------------------------------------------------------------------
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)         Sandoz, Inc., 227-15 North Conduit Ave.,
                         Sublingual Tablets, 0.5 mg            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)         Do.
                         Sublingual Tablets, 1 mg
----------------------------------------------------------------------------------------------------------------
ANDA 89-565             Vinblastine Sulfate Injection, 10 mg/ Hospira, Inc.
                         vial
----------------------------------------------------------------------------------------------------------------

    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
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