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Notice

Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 27 new drug applications (NDAs) and 58 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: August 20, 2010.

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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.

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SUPPLEMENTARY INFORMATION:

The holders of the applications listed in table 1 of 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 6-008Mesantoin (mephenytoin) TabletsNovartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080
NDA 9-000Cafergot (ergotamine tartrate and caffeine) Suppository, 1 milligram (mg)/100 mg and 2 mg/100 mgDo.
NDA 9-561Hypaque (diatrizoate sodium)GE Healthcare, Inc., 101 Carnegie Center, Princeton, NJ 08540
NDA 9-658Hydrocortisone TabletsSmith, Miller and Patch, Inc., Division of Cooper Vision, Inc., c/o Cooper Laboratories, Inc., 455 E. Middlefied Rd., Mountain View, CA 94043
NDA 9-942Deltra (prednisone) TabletsMerck & Co., Inc., P.O. Box 4, BLA-20, West Point, PA 19486-0004
NDA 10-051Hydeltra (prednisolone) TabletsDo.
NDA 10-255Meticortelone (prednisolone acetate) Injection and SuspensionSchering Corp., Galloping Hill Rd., Kenilworth, NJ 07033
NDA 12-885Winstrol (stanozolol) Tablets, 2 mgLundbeck, Inc., Four Parkway North, Deerfield, IL 60015
NDA 13-428Valpin (anisotropine methylbromide) TabletsEndo Pharmaceuticals, 100 Endo Blvd., Chadds Ford, PA 19317
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NDA 16-023Symmetrel (amantadine hydrochloride (HCl) USP) SyrupDo.
NDA 16-119Teslac (testolactone) Injection, 100 mg/milliliter (mL)Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000
NDA 16-403Hypaque-Cysto (diatrizoate meglumine) and Hypaque (diatrizoate meglumine)GE Healthcare, Inc.
NDA 16-636Narcar (naloxone HCl) InjectionEndo Pharmaceuticals
NDA 16-769Urispas (flavoxate HCl) Tablets, 100 mgOrtho-McNeil-Janssen Pharmaceutical, Inc., 1000 U.S. Highway 202, P.O. Box 3000, Raritan, NJ 08869-0602
NDA 17-022Methotrexate TabletsLederle Laboratories, A Division of American Cyanamid Co., 401 N. Middletown Rd., Pearl River, NY 10965
NDA 17-118Symmetrel (amantadine HCl USP) SyrupEndo Pharmaceuticals
NDA 17-255MPI DTPA Chelate multidose (kit for the preparation of technetium Tc-99m pentetate injection)Medi-Physics, Inc., d/b/a GE Healthcare, Inc., 101 Carnegie Center, Princeton, NJ 08540
NDA 17-264Technetium Tc-99m pentetate kitDo.
NDA 17-559Proventil (albuterol USP) Inhalation AerosolSchering Corp.
NDA 17-984Valcaps (diazepam) CapsulesHoffmann-LaRoche, Inc., Roche Pharmaceuticals, 340 Kingsland St., Nutley, NJ 07110-1199
NDA 18-101Symmetrel (amantadine HCl USP) TabletsEndo Pharmaceuticals
NDA 18-445Dolobid (diflunisal) Tablets, 250 mg and 500 mgMerck & Co., Inc.
ANDA 18-551Potassium Iodide Oral Solution USP, 1 gram (g)/mLRoxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228
NDA 18-706Hydergine LC (ergoloid mesylates) CapsulesNovartis Pharmaceuticals Corp.
NDA 18-746Vasocon-A (antazoline phosphate, 0.5% and naphazoline HCl, 0.05%) Ophthalmic SolutionDo.
ANDA 18-750Furosemide Tablets, 40 mgSandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893
NDA 19-309Vasotec (enalaprilat) InjectionBiovail Laboratories International SRL, c/o Biovail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807
NDA 21-007Agenerase (amprenavir), 50 mg and 150 mgGlaxoSmithKline, One Franklin Plaza, 200 North 16th St., Philadelphia, PA 19102
NDA 21-039Agenerase (amprenavir) Oral Solution, 15 mg/mLDo.
ANDA 40-149Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg and 7.5 mg/750 mgSandoz, Inc.
ANDA 40-312Innofem (estradiol tablets USP), 0.5 mg, 1 mg, and 2 mgNovo Nordisk, Inc., 100 College Rd. West, Princeton, NJ 08540
ANDA 60-568Urobiotic (oxytetracycline HCl, sulfamethizole, phenazopyridine HCl) CapsulesPfizer Inc., 235 East 42nd St., New York, NY 10017
ANDA 61-016Terra-Cortril (hydrocortisone acetate and oxytetracycline HCl)Do.
ANDA 61-410Veetids (penicillin V potassium for Oral Solution USP), 125 mg/5 mL and 250 mg/5 mLApothecon, c/o Bristol-Myers Squibb, P.O. Box 4000, Princeton, NJ 08543
ANDA 61-471Tetracycline HCl Capsules, 250 mgSandoz, Inc.
ANDA 61-781Erythromycin StearateTablets, 250 mgDo.
ANDA 61-965Nystatin Vaginal Tablets, 100,000 UnitsDo.
ANDA 62-014Oxytetracycline Capsules, 250 mgDo.
ANDA 62-065Nystatin Tablets, 500,000 UnitsDo.
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ANDA 62-590Kefurox (cefuroxime for injection USP), 750 mg/vial and 1.5 g/vialEli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285
ANDA 62-592Kefurox (cefuroxime for injection USP), 750 mg/vial and 1.5 g/vialDo.
ANDA 64-033Cefazolin Sodium ADD-Vantage Powder for Injection SolutionGlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929
ANDA 65-210Clarithromycin Extended-Release Tablets, 1,000 mgRanbaxy, Inc., U.S. Agent for Ranbaxy Laboratories Limited, 600 College Rd. East, Princeton, NJ 08540
ANDA 73-696Nitrofurantoin Capsules USP, 25 mg, 50 mg, and 100 mgWatson Laboratories, Inc., P.O. Box 450 39 Mt. Ebo Rd. South, Brewster, NY 10509
ANDA 74-648Lorazepam Oral Solution, 0.5 mg/5 mLRoxane Laboratories, Inc.
ANDA 74-764Ranitidine Injection USPBedford Laboratories, A division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146
ANDA 75-170Butorphanlol Tartrate Injection USP, 1 mg/mL and 2 mg/mLHospira, Inc., 275 N. Field Dr., Dept. 0389, Bldg. H2, Lake Forest, IL 60045-5046
ANDA 76-027Tamoxifen Citrate Tablets USP, 10 mg and 20 mgRoxane Laboratories, Inc.
ANDA 76-605Gabapentin Tablets USP, 600 mg and 800 mgDo.
ANDA 76-643Carbidopa and Levodopa Tablets for Oral Suspension, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mgDo.
ANDA 76-663Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mgKV Pharmaceutical Co., 2503 South Hanley Rd., St. Louis, MO 63144
ANDA 77-366Glimepiride Tablets USP, 3 mg and 6 mgRanbaxy Inc.
ANDA 81-096Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/30 mgMikart, Inc., 1750 Chattahoochee Ave., NW, Atlanta, GA 30318
ANDA 81-097Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/60 mgDo.
ANDA 81-226Hydrocodone Bitartrate and Acetaminophen Oral Solution, 5 mg/500 mg/15 mLDo.
ANDA 83-902Dexedrine (dextroamphetamine sulfate), 5 mg/mLGlaxoSmithKline, Research Triangle Park, NC 27709-3398
ANDA 84-353Bethanechol Chloride Tablets, 5 mgDo.
ANDA 84-378Bethanechol Chloride Tablets, 10 mg (Blue)Do.
ANDA 84-379Bethanechol Chloride Tablets, 10 mg (Pink)Do.
ANDA 84-383Bethanechol Chloride Tablets, 25 mg (Yellow)Do.
ANDA 84-384Bethanechol Chloride Tablets, 25 mgDo.
ANDA 84-617Hydralazine HCl and Reserpine Tablets, 25 mg/0.1 mgDo.
ANDA 84-773Prednisolone Tablets, 5 mgDo.
ANDA 84-774Prednisone Tablets, 5 mgDo.
ANDA 84-869Imipramine HCl Tablets, 25 mgDo.
ANDA 84-876Hydrochlorothiazide, Reserpine, and Hydralazine HCl Tablets, 15 mg/0.1 mg/25 mgDo.
ANDA 84-935Dexedrine (dextroamphetamine sulfate) TabletsGlaxoSmithKline, Research Triangle Park, NC 27709-3398
ANDA 84-956Hydralazine HCl Tablets, 25 mgSandoz, Inc.
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ANDA 85-088Hydralazine HCl Tablets, 50 mgDo.
ANDA 85-146Promethazine HCl Tablets, 25 mg and 50 mgDo.
ANDA 85-934Butabarbital Sodium Tablets, 30 mgDo.
ANDA 85-938Butabarbital Sodium Tablets, 15 mgDo.
ANDA 86-171Trichlormethiazide Tablets, 4 mgDo.
ANDA 86-505Hypaque-76 (diatrizoate meglumine and diatrizoate sodium injection USP)GE Healthcare, Inc.
ANDA 87-118Chlorthalidone Tablets, 50 mgSadoz, Inc.
ANDA 87-282Methocarbamol Tablets, 750 mgDo.
ANDA 87-283Methocarbamol Tablets, 500 mgDo.
ANDA 87-449Theophylline Oral Solution, 80 mg/15 mLRoxane Laboratories, Inc.
ANDA 87-462Theophylline Extended-Release Capsules, 260 mgSandoz, Inc.
ANDA 88-157Chlorpromazine HCl Intensol (chlorpromazine HCl oral concentrate USP), 30 mg/mLRoxane Laboratories, Inc.
ANDA 88-158Chlorpromazine HCl Intensol (chlorpromazine HCl oral concentrate USP), 100 mg/mLDo.
ANDA 88-193Triprolidine HCl and Pseudoephedrine HCl Tablets, 2.5 mg/60 mgSandoz, Inc.
ANDA 88-587Hydrochlorothiazide Oral SolutionRoxane Laboratories, Inc.
ANDA 89-127Mepro-Aspirin (aspirin and meprobamate) Tablets, 325 mg/200 mgSandoz, Inc.
ANDA 89-508Fluorouracil Injection USP, 50 mg/mLBedford Laboratories

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the 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 August 20, 2010. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the 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.

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Dated: June 15, 2010.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. 2010-17785 Filed 7-20-10; 8:45 am]

BILLING CODE 4160-01-S