Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six Abbreviated New Drug
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1 This document is scheduled to be published in the Federal Register on 06/19/2014 and available online at and on FDsys.gov P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0662] Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 86 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 DATE: [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD , SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in (c) (21 CFR (c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under (c) is without prejudice to refiling.
2 2 Table 1. ANDA Cefazolin for Injection USP, 500 milligrams (mg) and 1 gram (g) Aurobindo Pharma Ltd., c/o AuroMedics Pharma LLC, 6 Wheeling Rd. Dayton, NJ ANDA Ceftazidime for Injection USP, 500 mg, 1 g, and 2 g ANDA Ceftazidime for Injection USP, 6 g ANDA Ceftriaxone for Injection USP, 10 g ANDA Ceftriaxime for Injection, 250 mg, 500 mg, 1 g, and 2 g ANDA Cefotaxime for Injection USP, 10 g ANDA Cefotaxime for Injection USP ANDA Nateglinide Tablets, 60 mg and 120 mg Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA ANDA ANDA Cetirizine Hydrochloride (HCl) Syrup, 5 mg/5 milliliters (ml) Zolpidem Tartrate Tablets, 5 mg and 10 mg Ranbaxy Laboratories Limited, c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box , Research Triangle Park, NC ANDA Ondansetron Orally Nesher Pharmaceuticals (USA) LLC,
3 3 Disintegrating Tablets USP, 4 mg and 8 mg St. Charles Rock Rd., Bridgeton, MO ANDA Pravastatin Sodium Tablets, 10 mg, 20 mg, 30 mg, 40 mg, and 80 mg Pliva HRVATSKA, c/o Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ ANDA Fenoldopam Mesylate Injection USP, 10 mg (base)/ml Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA ANDA Ciprofloxacin Injection USP, 2 mg/ml ANDA Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg Baxter Healthcare Corp., 1620 Waukegan Rd., McGaw Park, IL Pliva HRVATSKA, c/o Barr Laboratories, Inc. ANDA ANDA Zolpidem Tartrate Tablets, 5 mg and 10 mg Sertraline HCl Oral Concentrate, 20 mg/ml Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV Ranbaxy Laboratories Limited, c/o Ranbaxy Inc. ANDA ANDA Ciprofloxacin Injection USP in 5% Dextrose, 2 mg/ml Ibuprofen Tablets USP, 400 mg, 600 mg, and 800 mg Bedford Laboratories, 300 Northfield Rd., Bedford, OH Quality Regulatory Consultants, U.S. Agent for Northstar Healthcare Holdings, 501 Ivy Lake Dr., Forest, VA ANDA Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg Synthon Pharmaceuticals, Inc.
4 4 ANDA Anastrozole Tablets, 1 mg ANDA Ranitidine HCl Solution, 15 mg/ml Ranbaxy Inc., U.S. Agaent for Ranbaxy Laboratories Limited ANDA Mitoxantrone Injection USP Washington Food and Drug Consultants, U.S. Agent for Fresenius Kabi Oncology Plc., 3631 Martins Dairy Circle, Olney, MD ANDA ANDA Nitrofurantoin Tablets, 50 mg and 100 mg Potassium Chloride Injection USP, 2 milliequivalents/ml Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO Baxter Healthcare Corp., W. IL Route 120, Round Lake, IL ANDA Hydrocortisone Tablets, 20 mg Sandoz Inc. ANDA Aminophylline Injection USP, 25 mg/ml Teva Parenteral Medicines, Inc. ANDA ANDA ANDA ANDA Glycopyrrolate Injection USP, 0.2 mg/ml Methyprednisolone Sodium Succinate for Injection USP, 125 mg Methylprednisolone Sodium Succinate for Injection USP, 500 mg Methyprednisolone Sodium Succinate for Injection USP, 1 g
5 5 ANDA Leucovorin Calcium for Injection, 50 mg/vial ANDA Halothane USP Hospira, Inc., 275 North Field Dr., Lake Forest, IL ANDA Alcohol in Dextrose Injection USP, 5%/5% ANDA Niacin Tablets, 50 mg Sandoz Inc. ANDA ANDA Isoproterenol HCl Injection USP, 0.2 mg/ml Dextroamphetamine Sulfate Tablets USP, 5 mg and 10 mg Baxter Healthcare Corp. Shire Development Inc., 725 Chesterbrook Blvd., Wayne, PA ANDA Promethazine HCl Tablets, 12.5 mg Sandoz Inc. ANDA Folic Acid Capsules, 1 mg ANDA ANDA Hydrochlorothiazide and Reserpine Tablets, 25 mg/0.125 mg Tablets, 35 mg ANDA Imipramine HCl Tablets, 50 mg ANDA Imipramine HCl Tablets, 10 mg ANDA Hydrochlorothiazide and Reserpine Tablets, 50 mg/0.125 mg. Estrogens, Esterified Tablets,
6 6 ANDA mg ANDA ANDA Novocaine (procaine HCl Injection USP) Dextroamphetamine Sulfate Tablets, 5 mg Hospira, Inc. Sandoz Inc. ANDA Dextroamphetamine Sulfate Tablets, 10 mg ANDA Tablets, 35 mg ANDA Triamcinolone Tablets, 4 mg ANDA Capsules, 35 mg ANDA Phentermine HCl Tablets, 8 mg ANDA Phentermine HCl Tablets USP, 8 mg ANDA ANDA ANDA ANDA Capsules, 35 mg Capsules, 35 mg Tablets, 35 mg A-Methapred (methylprednisolone sodium succinate for injection USP), 1,000 mg/vial Hospira, Inc.
7 7 ANDA ANDA ANDA ANDA ANDA ANDA ANDA A-Methapred (methylprednisolone sodium succinate for injection USP), 40 mg/vial A-Methapred (methylprednisolone sodium succinate for injection USP), 500 mg/vial A-Hydrocort (hydrocortisone sodium succinate for injection USP), 100 mg/vial A-Hydrocort (hydrocortisone sodium succinate for injection USP), 250 mg/vial A-Hydrocort (hydrocortisone sodium succinate for injection USP), 500 mg/vial A-Hydrocort (hydrocortisone sodium for injection USP), 1,000 mg/val Tablets, 35 mg Hospira, Inc. Sandoz Inc. ANDA ANDA Barbidonna Tablets (phenobarbital, hyoscyamine sulfate, scopolamine hydrobromide, and atropine sulfate) Barbidonna Elixir (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide) Meda Pharmaceuticals, Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300, Somerset, NJ
8 8 ANDA Butibel Elixir (sodium butabarbital and belladonna extract), 15 mg/5 ml and 15 mg/5 ml ANDA Phentermine HCl Capsules, 30 mg ANDA Phentermine HCl Capsules, 30 mg Sandoz Inc. ANDA ANDA ANDA Prochlorperazine Edisylate Injection USP Barbidonna No. 2 Tablets (phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide) 32 mg, mg, mg, and mg Heparin Lock Flush Solution USP, 2,500 units/ml Baxter Healthcare Corp. Meda Pharmaceuticals Hospira, Inc. ANDA Chlorpropamide Tablets, 100 mg Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY ANDA Chlorpropamide Tablets, 250 mg ANDA ANDA Hydroxyzine HCl Injection USP, 25 mg/ml Hydroxyzine HCl Injection USP, 50 mg/ml Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL ANDA % Lidocain HCl Injection Hospira, Inc.
9 9 USP ANDA Methotrexate Injection USP, 25 mg/ml Pharmachemie B.V., c/o Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA ANDA Azdone Tablets (hydrocodone bitartrate 5 mg and aspirin 500 mg) Schwarz Pharma, Inc., c/o UCB, Inc., 1950 Lake Park Dr., Smyrna, GA ANDA Cetirizine HCl Syrup, 5 mg/5ml Ranbaxy Laboratories Limited, c/o Ranbaxy Inc. ANDA Letrozole Tablets USP, 2.5 mg Synthon Pharmaceuticals, Inc. ANDA Mycophenolate Mofetil Tablets, 500 mg Dr. Reddy s Laboratories Limited, c/o Dr. Reddy s Laboratories, Inc., 200 Somerset Corporate Blvd., 7 th Floor, Bridgewater, NJ ANDA Polyethylene Glycol 3350 Powder for Oral Solution Paddock Laboratories, LLC, a Perrigo Co., 3940 Quebec Ave. North, Minneapolis, MN ANDA Polyethylene Glycol 3350 and Electrolytes for Oral Solution ANDA ANDA Clenz-Lyte (polyethylene glyol 3350 and electrolytes for oral solution) Mycophenolalte Mofetil Capsules USP, 250 mg Dr. Reddy s Laboratories Limited, c/o Dr. Reddy s Laboratories, Inc. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 table 1 in
10 10 this document, and all amendments and supplements thereto, is hereby withdrawn, effective [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&CAct (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: June 13, Leslie Kux, Assistant Commissioner for Policy. [FR Doc Filed 06/18/2014 at 8:45 am; Publication Date: 06/19/2014]
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