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Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug Applications and 68 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective Date: January 5, 2015.

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Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

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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 § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Table 1

Application No.DrugApplicant
NDA 002852Plexofer (multivitamins) SyrupMallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
NDA 008719Levo-Dromoran (levorphanol tartrate) Injection, 2 milligrams (mg)/milliliter (mL)Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 008720Levo-Dromoran (levorphanol tartrate) Tablets, 2 mgDo.
NDA 011777Sodium Phosphate P 32 SolutionMallinckrodt Inc.
NDA 012366Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate)Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 300, Somerset, NJ 08873-4120.
NDA 012708Diutensen-R (methyclothiazide and reserpine) Tablets, 2.5 mg/0.1 mgDo.
NDA 016245Vercyte (pipobroman) TabletsAbbVie, Inc., 1 North Waukegan Rd., Dept. PA 77/Bldg. AP30, North Chicago, IL 60064.
NDA 017463Motrin (ibuprofen) Tablets, 300 mg, 400 mg, 600 mg, and 800 mgMcNeil Consumer Healthcare Division of McNeil-PPC, Inc., 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.
NDA 018310Lymphazurin (isosulfan blue), 1%Covidien, 60 Middletown Ave., North Haven, CT 06473.
NDA 018340Aerobid (flunisolide) Inhalation Aerosol 1Roche Palo Alto LLC, c/o Genentech Inc., 1 DNA Way, South San Francisco, CA 94080-4990.
NDA 018731Buspar (buspirone hydrochloride (HCl)) Tablets, 5 mg, 10 mg, 15 mg, and 30 mgBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 019453Drixoral (dexbrompheniramine maleate, pseudoephedrine sulfate, and acetaminophen) Extended-Release Tablets, 3 mg, 60 mg, and 500 mgMerck Consumer Care, 556 Morris Ave., Summit, NJ 07901.
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NDA 019842Motrin (ibuprofen) Suspension, 100 mg/5 mLMcNeil Consumer Healthcare Division of McNeil-PPC, Inc.
NDA 020150Nicotrol TD (nicotine transdermal system), 5 mg/16 hour (hr), 10 mg/16 hr, and 15 mg/16 hrDo.
NDA 020707Skelid (tiludronate disodium) TabletsSanofi-Aventis U.S. LLC, 55 Corporate Dr., Mailstop 55C-205A, Bridgewater, NJ 08807.
NDA 021043RID Mousse (pyrethrins 0.33% and piperonyl butoxide 4.0%) Topical AerosolBayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ 07981-0915.
NDA 021082Tavist Allergy Sinus Headache (clemastine fumarate, pseudoephedrine HCl, and acetaminophen) Tablets, 0.335 mg, 30 mg, and 500 mgNovartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054.
NDA 021190Buspar (buspirone HCl) Capsules, 5 mg, 7.5 mg, 10 mg, and 15 mgBristol-Myers Squibb Co.
NDA 021335Gleevac (imatinib mesylate) Capsules, 50 mg and 100 mgNovartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936.
NDA 021745Ryzolt (tramadol HCl) Extended-Release Tablets, 100 mg, 200 mg, and 300 mgPurdue Pharma Products L.P., One Stamford Forum, Stamford, CT 06901-3431.
NDA 022217Valturna (aliskiren and valsartan) TabletsNovartis Pharmaceuticals Corp.
NDA 022470Nexcede (ketoprofen) Oral Soluble Films, 12.5 mgNovartis Consumer Health, Inc.
ANDA 040034Theophylline Extended-Release Tablets, 450 mgInwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc., Harborside Financial Center, Plaza Five, Suite 1900, Jersey City, NJ 07311.
ANDA 040052Theophylline Extended-Release Capsules, 100 mg, 125 mg, 200 mg, and 300 mgDo.
ANDA 040365Dextroamphetamine Sulfate Tablets, 5 mgNesher Pharmaceutical (USA) LLC, 13910 Saint Charles Rock Rd., Bridgeton, MO 63044.
ANDA 040367Dextroamphetamine Sulfate Tablets, 10 mgDo.
ANDA 060578Mycostatin Topical Powder (nystatin topical powder USP) 100,000 units/gram (g)Delcor Asset Corp., c/o Prestium Pharma Inc., 411 South State St., Suite E-100, Newtown, PA 18940.
ANDA 062162Erythromycin Estolate Capsules USP, 125 mg and 250 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 062256Erythromycin Ethylsuccinate Tablets USP, 400 mgDo.
ANDA 062773Cephalexin Capsules USP 250 mgDo.
ANDA 062850Cephradine Capsules USP 250 mgDo.
ANDA 062851Cephradine Capsules USP 500 mgDo.
ANDA 062858Cephradine for Oral Suspension USP 125 mg/5 mLDo.
ANDA 062859Cephradine for Oral Suspension USP, 250 mg/5 mLDo.
ANDA 063016Cefazolin for Injection USP 250 mg/vial, 500 mg/vial, and 1 g/vialTeva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 063028Erythromycin Delayed-Release Tablets USP, 333 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 063086Erythromycin Delayed-Release Tablets, 333 mgDo.
ANDA 063098Erythromycin Delayed-Release Capsules USP, 250 mgDo.
ANDA 063179Erythromycin Stearate Tablets USP 500 mgANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 56623.
ANDA 064191Cefuroxime for Injection USP 7.5 g/vialTeva Pharmaceuticals USA.
ANDA 064192Cefuroxime for Injection USP 750 mg/vial and 1.5 g/vialDo.
ANDA 065032Doxycycline Capsules USP 50 mg and 100 mgSandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 065227Ceftriaxone for Injection USP, 250 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vialTeva Pharmaceuticals USA.
ANDA 065262Ceftriaxone for Injection USP, 1 g/vial and 2 g/vialDo.
ANDA 065274Ceftriaxone for Injection USP, 10 g/vialDo.
ANDA 070034Sulfamethoxazole and Trimethoprim Tablets USP 400 mg/80 mgTeva Pharmaceuticals USA.
ANDA 070216Sulfamethoxazole and Trimethoprim Tablets USP 800 mg/160 mgBarr Laboratories Inc., Subsidiary of Teva Pharmaceuticals.
ANDA 072410Indomethacin Extended-Release Capsules, 75 mgInwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc.
ANDA 072499Propranolol HCl Extended-Release Capsules, 60 mgDo.
ANDA 072500Propranolol HCl Extended-Release Capsules, 80 mgDo.
ANDA 072501Propranolol HCl Extended-Release Capsules, 120 mgDo.
ANDA 072502Propranolol HCl Extended-Release Capsules, 160 mgDo.
ANDA 072619Albuterol Sulfate Tablets USP 2 mgTeva Pharmaceuticals USA.
ANDA 072620Albuterol Sulfate Tablets USP 4 mgDo.
ANDA 073095Clemastine Fumerate Syrup, 0.5 mg/5 mLDo.
ANDA 073531Potassium Chloride Extended-Release Capsules USP, 8 milliequivalents (mEq)Do.
ANDA 073532Potassium Chloride Extended-Release Capsules USP, 10 mEqDo.
ANDA 073667Nortriptyline HCl Capsules, 10 mg, 25 mg, 50 mg, and 75 mgDo.
ANDA 074043Piroxicam Capsules USP, 10 mg and 20 mgMylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505.
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ANDA 074126Atenolol Tablets USP, 25 mg, 50 mg, and 100 mgDo.
ANDA 074589Minoxidil Topical Solution, 2%Teva Pharmaceuticals USA.
ANDA 074828Acyclovir Capsules, 200 mgDo.
ANDA 074849Clomipramine HCl Capsules, 25 mg, 50 mg, and 75 mgDo.
ANDA 074879Ketoprofen Extended-Release Capsules, 200 mgAlkermes Gainesville LLC, 1300 Gould Dr., Gainesville, GA 30504.
ANDA 074976Acyclovir Tablets USP, 400 mg and 800 mgMylan Pharmaceuticals, Inc.
ANDA 074977Acyclovir Capsules USP, 200 mgDo.
ANDA 075161Ticlopidine HCl Tablets USP, 250 mgDo.
ANDA 075472Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mgDo.
ANDA 075934Nizatidine Capsules USP, 150 mg and 300 mgDo.
ANDA 076036Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mgDo.
ANDA 076969Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mgSandoz, Inc.
ANDA 077136Terbinafine HCl Tablets, 250 mgMylan Pharmaceuticals, Inc.
ANDA 077163Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mgDo.
ANDA 077254Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg, and 500 mgDo.
ANDA 077486Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mgDo.
ANDA 077705Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg and 20 mg/12.5 mgDo.
ANDA 077934Meloxicam Tablets USP, 7.5 mg and 15 mgDo.
ANDA 077976Cromolyn Sodium Nasal Solution USP, 5.2 mg/1 sprayHH & P LLC, c/o Kuker Regulatory Consulting, LLC, 18 Dunbar Way, Mahtomedi, MN 55115.
ANDA 078638Alendronate Sodium Tablets USP, 35 mg and 70 mgMylan Pharmaceuticals, Inc.
ANDA 078731Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1,000 mgDo.
ANDA 079184Ursodiol Tablets USP, 250 mg and 500 mgTeva Pharmaceuticals USA.
ANDA 081295Estradiol Tablets USP, 0.5 mgBristol-Myers Squibb Co.
ANDA 084499Estradiol Tablets USP, 1 mgDo.
ANDA 084500Estradiol Tablets USP, 2 mgDo.
ANDA 085794Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mgMutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 085795Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mgDo.
ANDA 087176Chlorthalidone Tablets USP, 50 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 087653Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mgMutual Pharmaceutical Co., Inc.
ANDA 088833Triprolidine HCl, pseudoephedrine HCl, and Codeine Phosphate Cough Syrup, 1.25 mg/5 mL, 30 mg/5 mL, and 10 mg/5 mLWockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053.
ANDA 088896Promethazine VC with Codeine (promethazine HCl, phenylephrine HCl, and codeine phosphate) Cough Syrup, 6.25 mg/5 mL, 5 mg/5 mL, and 10 mg/5 mLDo.
NDA 202343Juvisync (sitagliptin and simvastatin) Tablets, 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mgMerck Sharp & Dohme Corp., 351 North Sumneytown Pike, P.O. Box 1000, UG2CD-015, North Wales, PA 19454.
1 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 January 5, 2015. 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.

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Dated: December 1, 2014.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2014-28541 Filed 12-4-14; 8:45 am]