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Notice

Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New Drug Applications

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ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 35 new drug applications (NDAs) and 64 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: April 18, 2012.

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 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 § 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 005545Dicumarol TabletsAbbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.
NDA 005845Benadryl (diphenhydramine hydrochloride (HCl)), Benadryl with Ephedrine Sulfate, and Caladryl (diphenhydramine HCl and calamine)McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.
NDA 006146Benadryl (diphenhydramine HCl)) InjectionDo.
NDA 006773Artane (trihexyphenidyl HCl) Tablets and Capsules and Artane (trihexyphenidyl) ElixirLederle Laboratories, d/b/a Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299.
NDA 009486Benadryl (diphenhydramine HCl)) Injection Preservative FreeMcNeil Consumer Healthcare.
NDA 010021Placidyl (ethchlorvynol) CapsulesAbbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60064.
NDA 011552Stelazine (trifluoperazine HCl)GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.
NDA 012524Enduron (methyclothiazide) Tablets, 2.5 milligrams (mg) and 5 mgAbbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.
NDA 012775Enduronyl and Enduronyl Forte (methyclothiazide and deserpidine) TabletsDo.
NDA 014684Aventyl (nortriptyline HCl) CapsulesEli Lilly and Co., Lilly Corp. Center, Indianapolis, IN 46285.
NDA 017577Ditropan (oxybutynin chloride) TabletsJanssen Pharmaceuticals Inc., c/o Johnson & Johnson Pharmaceutical Research and Development, LLC, 920 Route 202, P.O. Box 300, Raritan, NJ 08869.
NDA 018473Ventolin (albuterol) Inhalation Aerosol1GlaxoSmithKline.
NDA 018557Fansidar (sulfadoxine and pyrimethamine) Tablets, 500 mg and 25 mgHoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199.
NDA 018709Capozide (captopril and hydrochlorothiazide) TabletsBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 018814Heparin Sodium in 5% Dextrose InjectionBaxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085.
NDA 019297Novantrone (mitoxantrone HCl) InjectionEMD Serono, One Technology Place, Rockland, MA 02370.
NDA 019508Axid (nizatidine) CapsulesSmithKline Beecham Corp., d/b/a GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.
NDA 019915Monopril (fosinopril sodium) Tablets, 10 mg, 20 mg, and 40 mgBristol-Myers Squibb Co.
NDA 019946Nuromax (doxacurium chloride) Injection 1 mg/milliliter (mL)Abbott Laboratories, P76/Bldg. AP30-1E, Abbott Park, IL 60064-6157.
NDA 019960Manoplax (flosequinan) TabletsDo.
NDA 020057Ceredase (alglucerase) InjectionGenzyme Corp., 500 Kendall St., Cambridge, MA 02142.
NDA 020088Norplant System (levonorgestrel) ImplantsWyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299.
NDA 020101Prozac (fluoxetine HCl) Oral Solution, 20 mg/5 mLEli Lilly and Co.
NDA 020236Serevent (salmeterol xinafoate) Inhalation Aerosol1GlaxoSmithKline.
NDA 020286Monopril-HCT (fosinopril sodium and hydrochlorothiazide) Tablets, 20 mg/12.5 mg and 10 mg/12.5 mgBristol-Myers Squibb Co.
NDA 020403Zofran (ondansetron HCl) InjectionGlaxo Wellcome Manufacturing Pte Limited, d/b/a GlaxoSmithKline, 1250 Collegeville Rd., UP4110, Collegeville, PA 19426.
NDA 020627Norplant II System (levonorgestrel) ImplantsWyeth Pharmaceuticals, Inc.
NDA 020828Fortovase (saquinavir) Capsules, 200 mgHoffman-La Roche, Inc.
NDA 020860Levlite (ethinyl estradiol and levonorgestrel) TabletsBayer HealthCare Pharmaceuticals Inc., P.O. Box 1000, Montville, NJ 07045.
NDA 020984Raplon (rapacuronium bromide) for InjectionOrganon USA Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 021120Novantrone (mitoxantrone HCl) InjectionEMD Serono.
NDA 021793Reglan ODT (metoclopramide) TabletsMeda Pharmaceuticals Inc., 200 North Cobb Parkway, Suite 428, Marietta, GA 30062.
ANDA 040207Prochlorperazine Maleate Tablets USP, 5 mg and 10 mgDuramed Pharmaceuticals, Inc., 400 Chestnut Rd., Woodcliff Lake, NJ 07677.
ANDA 040231Chlorpromazine HCl Oral Concentrate USP, 30 mg/mLPharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605.
NDA 050526Staticin (erythromycin) Topical Solution, 1.5%Bristol-Myers Squibb Co.
NDA 050687Banan (cefpodoxime proxetil) Tablets, 100 mg and 200 mgDaiichi Sankyo, Inc., 399 Thornall St., 11th Floor, Edison, NJ 08837.
NDA 050688Banan (cefpodoxime proxetil) Granules for Oral Suspension, 50 mg/5 mL and 100 mg/5 mLDo.
ANDA 064098Amikacin Sulfate Injection USP, 250 mg (base)/mLHospira, Inc., 275 North Field Dr., Bldg. H2-2, Lake Forest, IL 60045.
ANDA 064106Mitomycin for Injection USP, 20 mg VialDo.
ANDA 070505Metoclopramide Injection USP, 5 mg/mLDo.
ANDA 070506Metoclopramide Injection USP, 5 mg/mLDo.
ANDA 070566Nitropress (sodium nitroprusside for Injection USP), 50 mgDo.
ANDA 071015Haloperidol Oral Solution USP, 2 mg/mLTeva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.
ANDA 071554Thiothixene HCl Oral Solution USP, 5 mg/mLDo.
ANDA 073058Fluphenazine HCl Oral Solution USP, 5 mg/mLDo.
ANDA 073479Pentamidine Isethionate for Injection, 300 mg VialHospira, Inc.
ANDA 074636Iopamidol Injection USP, 41%, 51%, 61%, 76%Do.
ANDA 074898Iopamidol Injection USP, 41%, 51%, 61%, 76%Do.
ANDA 075065Acyclovir Sodium for InjectionDo.
ANDA 075176Haloperidol Decanoate Injection, 50 mg/mL and 100 mg/mLDo.
ANDA 075409Midazolam HCl Injection, 1 mg (base)/mL and 5 mg (base)/mLDo.
ANDA 075884Milrinone Lactate Injection, 1 mg/mLDo.
ANDA 076306Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mgRoxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 077138Ciprofloxacin Injection USP in 5% Dextrose InjectionTeva Pharmaceuticals USA.
ANDA 077223Terbinafine HCl Tablets, 250 mg (base)Roxane Laboratories, Inc.
ANDA 077784Risperidone Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mgRatiopharm Inc., c/o Columbia Pharma Consulting Services Inc., 490 Northwest Datewood Dr., Suite 400, Issaquah, WA 98027.
ANDA 078241Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg (base)Roxane Laboratories, Inc.
ANDA 078318Sumatriptan Injection, 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mLTEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 078416Prednisolone Sodium Phosphate Oral Solution, 5 mg (base)/5 mLVintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811.
ANDA 078517Venlafaxine HCl Tablets, 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base), and 100 mg (base)PLIVA Hrvatska d.o.o., c/o Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677
ANDA 080997Succinylcholine Chloride Injection USP, 20 mg/mLOrganon USA Inc.
ANDA 081125Dexamethasone Sodium Phosphate Injection USP, 4 mg/mLTEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 081126Dexamethasone Sodium Phosphate Injection USPDo.
ANDA 081298Chlorzoxazone Tablets, 250 mgRanbaxy Inc., U.S. Agent for Ohm, 600 College Rd. East, Princeton, NJ 08540.
ANDA 081299Chlorzoxazone Tablets, 500 mgDo.
ANDA 081310Fluphenazine HCl Elixir USP, 2.5 mg/5 mLTeva Pharmaceuticals USA.
ANDA 087005Trichlormethiazide Tablets, 4 mgPar Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 087007Trichlormethiazide Tablets, 2 mgDo.
ANDA 087032Chlorpromazine HCl Oral Concentrate USP, 30 mg/mLMorton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG, 6451 West Main St., Morton Grove, IL 60053.
ANDA 087053Chlorpromazine HCl Oral Concentrate USP, 100 mg/mLDo.
ANDA 087406Oxycodone and Acetaminophen Tablets USP, 5 mg/325 mgBarr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 087585Potassium Chloride for Injection Concentrate USP, 2 mEq/mLLuitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O. Box 9001, Shirley, NY 11967.
ANDA 088143Trifluoperazine Oral Solution USP, 10 mg/mLMorton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG.
ANDA 088194Thioridazine HCl Tablets USP, 50 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 088227Thioridazine HCl Oral Solution USP (Concentrate), 100 mg/mLMorton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG.
ANDA 088258Thioridazine HCl Oral Solution USP (Concentrate), 30 mg/mLDo.
ANDA 088270Thioridazine HCl Tablets USP, 10 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 088271Thioridazine HCl Tablets USP, 15 mgDo.
ANDA 088272Thioridazine HCl Tablets USP, 25 mgDo.
ANDA 088273Thioridazine HCl Tablets USP, 100 mgDo.
ANDA 088456Thioridazine HCl Tablets USP, 100 mgTeva Pharmaceuticals USA.
ANDA 088493Thioridazine HCl Tablets USP, 10 mgDo.
ANDA 088850Hydroflumethiazide Tablets USP, 50 mgPar Pharmaceutical, Inc.
ANDA 088907Reserpine and Hydroflumethiazide Tablets, 0.125 mg/50 mgDo.
ANDA 088933Sulfinpyrazone Tablets, 100 mgDo.
ANDA 088934Sulfinpyrazone Capsules USP, 200 mgDo.
ANDA 089135Methyclothiazide Tablets, 2.5 mgDo.
ANDA 089136Methyclothiazide Tablets, 5 mgDo.
ANDA 089173A-MethaPred (methylprednisolone sodium succinate for injection USP), 500 mg (base)/VialHospira, Inc.
ANDA 089174A-MethaPred (methylprednisolone sodium succinate for injection USP), 1 gram (base)/VialDo.
ANDA 089207Methylprednisolone Tablets USP, 16 mgPar Pharmaceutical, Inc.
ANDA 089208Methylprednisolone Tablets USP, 24 mgDo.
ANDA 089209Methylprednisolone Tablets USP, 32 mgDo.
ANDA 089457Perphenazine Tablets USP, 16 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 089602Thioridazine HCl Oral Solution USP, 30 mg/mLTeva Pharmaceuticals USA.
ANDA 089603Thioridazine HCl Oral Solution USP, 100 mg/mLDo.
ANDA 089624Reversol (edrophonium chloride injection USP), 10 mg/mL)Organon USA Inc.
ANDA 089657Methocarbamol and Aspirin Tablets, 400 mg/325 mgPar Pharmaceutical, Inc.
ANDA 089708Perphenazine Tablets USP, 4 mgIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
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 albuterol or salmeterol metered-dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December 7, 2006).

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (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 April 18, 2012. 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 in this document 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: February 16, 2012.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 2012-6591 Filed 3-16-12; 8:45 am]

BILLING CODE 4160-01-P