Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68
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1 This document is scheduled to be published in the Federal Register on 12/05/2014 and available online at and on FDsys.gov P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1795] Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 23 new drug applications (NDAs) and 68 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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. 6248, 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 pursuant to 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 NDA Plexofer (multivitamins) Syrup Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO NDA Levo-Dromoran (levorphanol tartrate) Injection, 2 milligrams ()/milliliter (ml) Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ NDA Levo-Dromoran (levorphanol tartrate) Tablets, 2 NDA Sodium Phosphate P 32 Solution Mallinckrodt Inc. NDA Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 300, Somerset, NJ NDA Diutensen-R (methyclothiazide and reserpine) Tablets, 2.5 /0.1 NDA Vercyte (pipobroman) Tablets AbbVie, Inc., 1 North Waukegan Rd., Dept. PA 77/Bldg. AP30, North Chicago, IL NDA Motrin (ibuprofen) Tablets, 300, 400, 600, and 800 NDA Lymphazurin (isosulfan blue), 1 % NDA NDA NDA NDA NDA Aerobid (flunisolide) Inhalation Aerosol 1 Buspar (buspirone hydrochloride (HCl)) Tablets, 5, 10, 15, and 30 Drixoral (dexbrompheniramine maleate, pseudoephedrine sulfate, and acetaminophen) Extended-Release Tablets, 3, 60, and 500 Motrin (ibuprofen) Suspension, 100 /5 ml Nicotrol TD (nicotine transdermal system), 5 /16 McNeil Consumer Healthcare Division of McNeil-PPC, Inc., 7050 Camp Hill Rd., Fort Washington, PA Covidien, 60 Middletown Ave., North Haven, CT Roche Palo Alto LLC, c/o Genentech Inc., 1 DNA Way, South San Francisco, CA Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ Merck Consumer Care, 556 Morris Ave., Summit, NJ McNeil Consumer Healthcare Division of McNeil-PPC, Inc.
3 3 hour (hr), 10 /16 hr, and 15 /16 hr NDA Skelid (tiludronate disodium) Tablets Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Mailstop 55C-205A, Bridgewater, NJ NDA RID Mousse (pyrethrins 0.33% and piperonyl butoxide 4.0%) Topical Aerosol NDA NDA NDA NDA NDA NDA ANDA ANDA ANDA ANDA Tavist Allergy Sinus Headache (clemastine fumarate, pseudoephedrine HCl, and acetaminophen) Tablets, 0.335, 30, and 500 Buspar (buspirone HCl) Capsules, 5, 7.5, 10, and 15 Gleevac (imatinib mesylate) Capsules, 50 and 100 Ryzolt (tramadol HCl) Extended- Release Tablets, 100, 200, and 300 Valturna (aliskiren and valsartan) Tablets Nexcede (ketoprofen) Oral Soluble Films, 12.5 Theophylline Extended-Release Tablets, 450 Theophylline Extended-Release Capsules, 100, 125, 200, and 300 Dextroamphetamine Sulfate Tablets, 5 Dextroamphetamine Sulfate Tablets, 10 Bayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ Bristol-Myers Squibb Co. Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ Purdue Pharma Products L.P., One Stamford Forum, Stamford, CT Novartis Pharmaceuticals Corp. Novartis Consumer Health, Inc. Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc., Harborside Financial Center, Plaza Five, Suite 1900, Jersey City, NJ Nesher Pharmaceutical (USA) LLC, Saint Charles Rock Rd., Bridgeton, MO ANDA Mycostatin Topical Powder (nystatin topical powder USP) Delcor Asset Corp., c/o Prestium Pharma Inc., 411 South State St.,
4 4 100,000 units/gram (g) Suite E-100, Newtown, PA ANDA Erythromycin Estolate Capsules USP, 125 and 250 ANDA Erythromycin Ethylsuccinate Tablets USP, 400 ANDA Cephalexin Capsules USP 250 ANDA Cephradine Capsules USP 250 ANDA Cephradine Capsules USP 500 ANDA Cephradine for Oral Suspension USP 125 /5 ml ANDA Cephradine for Oral Suspension USP, 250 /5 ml ANDA Cefazolin for Injection USP 250 /vial, 500 /vial, and 1 g/vial ANDA Erythromycin Delayed-Release Tablets USP, 333 ANDA Erythromycin Delayed-Release Tablets, 333 ANDA Erythromycin Delayed-Release Capsules USP, 250 ANDA Erythromycin Stearate Tablets USP 500 Barr Laboratories, Inc., Subsidiary of, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677, 425 Privet Rd., Horsham, PA Barr Laboratories, Inc., Subsidiary of ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN ANDA Cefuroxime for Injection USP 7.5 g/vial ANDA Cefuroxime for Injection USP 750 /vial and 1.5 g/vial ANDA Doxycycline Capsules USP 50 and 100 ANDA Ceftriaxone for Injection USP, 250 /vial, 500 /vial, 1 g/vial, and 2 g/vial ANDA Ceftriaxone for Injection USP, 1 g/vial and 2 g/vial ANDA Ceftriaxone for Injection USP, 10 g/vial Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893
5 5 ANDA Sulfamethoxazole and Trimethoprim Tablets USP 400 /80 ANDA Sulfamethoxazole and Trimethoprim Tablets USP Barr Laboratories Inc., Subsidiary of Teva Pharmaceuticals 800 /160 ANDA Indomethacin Extended-Release Capsules, 75 Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc. ANDA Propranolol HCl Extended- Release Capsules, 60 ANDA Propranolol HCl Extended- Release Capsules, 80 ANDA Propranolol HCl Extended- Release Capsules, 120 ANDA Propranolol HCl Extended- Release Capsules, 160 ANDA Albuterol Sulfate Tablets USP 2 ANDA Albuterol Sulfate Tablets USP 4 ANDA Clemastine Fumerate Syrup, 0.5 /5 ml ANDA Potassium Chloride Extended- Release Capsules USP, 8 milliequivalents (meq) ANDA Potassium Chloride Extended- Release Capsules USP, 10 meq ANDA Nortriptyline HCl Capsules, 10 ANDA , 25, 50, and 75 Piroxicam Capsules USP, 10 and 20 Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV ANDA Atenolol Tablets USP, 25, 50, and 100 ANDA Minoxidil Topical Solution, 2% ANDA Acyclovir Capsules, 200 ANDA Clomipramine HCl Capsules, 25, 50, and 75 ANDA Ketoprofen Extended-Release Capsules, 200 Alkermes Gainesville LLC, 1300 Gould Dr., Gainesville, GA ANDA Acyclovir Tablets USP, 400 Mylan Pharmaceuticals, Inc.
6 6 and 800 ANDA Acyclovir Capsules USP, 200 ANDA Ticlopidine HCl Tablets USP, 250 ANDA Enalapril Maleate Tablets USP, 2.5, 5, 10, and 20 ANDA Nizatidine Capsules USP, 150 and 300 ANDA Quinapril Tablets USP, 5, 10, 20, and 40 ANDA Metoprolol Succinate Extended- Sandoz, Inc. Release Tablets USP, 25, 50, 100, and 200 ANDA Terbinafine HCl Tablets, 250 Mylan Pharmaceuticals, Inc. ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA Sumatriptan Succinate Tablets, 25, 50, and 100 Divalproex Sodium Delayed- Release Tablets USP, 125, 250, and 500 Glimepiride Tablets USP, 1, 2, and 4 Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 /12.5 and 20 /12.5 Meloxicam Tablets USP, 7.5 and 15 Cromolyn Sodium Nasal Solution USP, 5.2 /1 spray Alendronate Sodium Tablets USP, 35 and 70 Levetiracetam Tablets, 250, 500, 750, and 1,000 Ursodiol Tablets USP, 250 and 500 HH & P LLC, c/o Kuker Regulatory Consulting, LLC, 18 Dunbar Way, Mahtomedi, MN Mylan Pharmaceuticals, Inc. ANDA Estradiol Tablets USP, 0.5 Bristol-Myers Squibb Co. ANDA Estradiol Tablets USP, 1
7 7 ANDA Estradiol Tablets USP, 2 ANDA Acetaminophen and Codeine Phosphate Tablets USP, 300 /30 Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA ANDA Acetaminophen and Codeine Phosphate Tablets USP, 300 /15 ANDA Chlorthalidone Tablets USP, 50 ANDA ANDA ANDA NDA Acetaminophen and Codeine Phosphate Tablets USP, 300 /60 Triprolidine HCl, Pseudoephedrine HCl, and Codeine Phosphate Cough Syrup, 1.25 /5 ml, 30 /5 ml, and 10 /5 ml Promethazine VC with Codeine (promethazine HCl, phenylephrine HCl, and codeine phosphate) Cough Syrup, 6.25 /5 ml, 5 /5 ml, and 10 /5 ml Juvisync (sitagliptin and simvastatin) Tablets, 100 /10, 100 /20, and 100 /40 Ivax Pharmaceuticals, Inc., Subsidiary of, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ Mutual Pharmaceutical Co., Inc. Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL Merck Sharp & Dohme Corp., 351 North Sumneytown Pike, P.O. Box 1000, UG2CD-015, North Wales, PA This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any flunisolide metered-dose inhalers (see 75 FR 19213, April 14, 2010). 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 this document, and all amendments and supplements thereto, is hereby withdrawn, effective [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
8 8 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&C Act (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: December 1, Leslie Kux, Associate Commissioner for Policy. [FR Doc Filed 12/04/2014 at 8:45 am; Publication Date: 12/05/2014]
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