Document ID: FDA-2010-N-0318-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications: Novartis Pharmaceuticals Corp. et al.
Posted Date: 2010-07-21T04:00Z

[Federal Register: July 21, 2010 (Volume 75, Number 139)]
[Notices]               
[Page 42455-42458]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy10-83]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0318]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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be withdrawn.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.

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 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 Sec.  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 Sec.  314.150(c) is without prejudice to 
refiling.

                                                    Table 1.
----------------------------------------------------------------------------------------------------------------
     Application No.                       Drug                                      Applicant
----------------------------------------------------------------------------------------------------------------
NDA 6-008                 Mesantoin (mephenytoin) Tablets         Novartis Pharmaceuticals Corp., One Health
                                                                   Plaza, East Hanover, NJ 07936-1080
----------------------------------------------------------------------------------------------------------------
NDA 9-000                 Cafergot (ergotamine tartrate and       Do.
                           caffeine) Suppository, 1 milligram
                           (mg)/100 mg and 2 mg/100 mg
----------------------------------------------------------------------------------------------------------------
NDA 9-561                 Hypaque (diatrizoate sodium)            GE Healthcare, Inc., 101 Carnegie Center,
                                                                   Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
NDA 9-658                 Hydrocortisone Tablets                  Smith, Miller and Patch, Inc., Division of
                                                                   Cooper Vision, Inc., c/o Cooper Laboratories,
                                                                   Inc., 455 E. Middlefied Rd., Mountain View,
                                                                   CA 94043
----------------------------------------------------------------------------------------------------------------
NDA 9-942                 Deltra (prednisone) Tablets             Merck & Co., Inc., P.O. Box 4, BLA-20, West
                                                                   Point, PA 19486-0004
----------------------------------------------------------------------------------------------------------------
NDA 10-051                Hydeltra (prednisolone) Tablets         Do.
----------------------------------------------------------------------------------------------------------------
NDA 10-255                Meticortelone (prednisolone acetate)    Schering Corp., Galloping Hill Rd.,
                           Injection and Suspension                Kenilworth, NJ 07033
----------------------------------------------------------------------------------------------------------------
NDA 12-885                Winstrol (stanozolol) Tablets, 2 mg     Lundbeck, Inc., Four Parkway North, Deerfield,
                                                                   IL 60015
----------------------------------------------------------------------------------------------------------------
NDA 13-428                Valpin (anisotropine methylbromide)     Endo Pharmaceuticals, 100 Endo Blvd., Chadds
                           Tablets                                 Ford, PA 19317
----------------------------------------------------------------------------------------------------------------

[[Page 42456]]

NDA 16-023                Symmetrel (amantadine hydrochloride     Do.
                           (HCl) USP) Syrup
----------------------------------------------------------------------------------------------------------------
NDA 16-119                Teslac (testolactone) Injection, 100    Bristol-Myers Squibb Co., P.O. Box 4000,
                           mg/milliliter (mL)                      Princeton, NJ 08543-4000
----------------------------------------------------------------------------------------------------------------
NDA 16-403                Hypaque-Cysto (diatrizoate meglumine)   GE Healthcare, Inc.
                           and Hypaque (diatrizoate meglumine)
----------------------------------------------------------------------------------------------------------------
NDA 16-636                Narcar (naloxone HCl) Injection         Endo Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
NDA 16-769                Urispas (flavoxate HCl) Tablets, 100    Ortho-McNeil-Janssen Pharmaceutical, Inc.,
                           mg                                      1000 U.S. Highway 202, P.O. Box 3000,
                                                                   Raritan, NJ 08869-0602
----------------------------------------------------------------------------------------------------------------
NDA 17-022                Methotrexate Tablets                    Lederle Laboratories, A Division of American
                                                                   Cyanamid Co., 401 N. Middletown Rd., Pearl
                                                                   River, NY 10965
----------------------------------------------------------------------------------------------------------------
NDA 17-118                Symmetrel (amantadine HCl USP) Syrup    Endo Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
NDA 17-255                MPI DTPA Chelate multidose (kit for     Medi-Physics, Inc., d/b/a GE Healthcare, Inc.,
                           the preparation of technetium Tc-99m    101 Carnegie Center, Princeton, NJ 08540
                           pentetate injection)
----------------------------------------------------------------------------------------------------------------
NDA 17-264                Technetium Tc-99m pentetate kit         Do.
----------------------------------------------------------------------------------------------------------------
NDA 17-559                Proventil (albuterol USP) Inhalation    Schering Corp.
                           Aerosol
----------------------------------------------------------------------------------------------------------------
NDA 17-984                Valcaps (diazepam) Capsules             Hoffmann-LaRoche, Inc., Roche Pharmaceuticals,
                                                                   340 Kingsland St., Nutley, NJ 07110-1199
----------------------------------------------------------------------------------------------------------------
NDA 18-101                Symmetrel (amantadine HCl USP) Tablets  Endo Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
NDA 18-445                Dolobid (diflunisal) Tablets, 250 mg    Merck & Co., Inc.
                           and 500 mg
----------------------------------------------------------------------------------------------------------------
ANDA 18-551               Potassium Iodide Oral Solution USP, 1   Roxane Laboratories, Inc., 1809 Wilson Rd.,
                           gram (g)/mL                             Columbus, OH 43228
----------------------------------------------------------------------------------------------------------------
NDA 18-706                Hydergine LC (ergoloid mesylates)       Novartis Pharmaceuticals Corp.
                           Capsules
----------------------------------------------------------------------------------------------------------------
NDA 18-746                Vasocon-A (antazoline phosphate, 0.5%   Do.
                           and naphazoline HCl, 0.05%)
                           Ophthalmic Solution
----------------------------------------------------------------------------------------------------------------
ANDA 18-750               Furosemide Tablets, 40 mg               Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC
                                                                   27893
----------------------------------------------------------------------------------------------------------------
NDA 19-309                Vasotec (enalaprilat) Injection         Biovail Laboratories International SRL, c/o
                                                                   Biovail Technologies Ltd., 700 Route 202/206
                                                                   North, Bridgewater, NJ 08807
----------------------------------------------------------------------------------------------------------------
NDA 21-007                Agenerase (amprenavir), 50 mg and 150   GlaxoSmithKline, One Franklin Plaza, 200 North
                           mg                                      16th St., Philadelphia, PA 19102
----------------------------------------------------------------------------------------------------------------
NDA 21-039                Agenerase (amprenavir) Oral Solution,   Do.
                           15 mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 40-149               Hydrocodone Bitartrate and              Sandoz, Inc.
                           Acetaminophen Tablets USP, 5 mg/500
                           mg and 7.5 mg/750 mg
----------------------------------------------------------------------------------------------------------------
ANDA 40-312               Innofem (estradiol tablets USP), 0.5    Novo Nordisk, Inc., 100 College Rd. West,
                           mg, 1 mg, and 2 mg                      Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
ANDA 60-568               Urobiotic (oxytetracycline HCl,         Pfizer Inc., 235 East 42nd St., New York, NY
                           sulfamethizole, phenazopyridine HCl)    10017
                           Capsules
----------------------------------------------------------------------------------------------------------------
ANDA 61-016               Terra-Cortril (hydrocortisone acetate   Do.
                           and oxytetracycline HCl)
----------------------------------------------------------------------------------------------------------------
ANDA 61-410               Veetids (penicillin V potassium for     Apothecon, c/o Bristol-Myers Squibb, P.O. Box
                           Oral Solution USP), 125 mg/5 mL and     4000, Princeton, NJ 08543
                           250 mg/5 mL
----------------------------------------------------------------------------------------------------------------
ANDA 61-471               Tetracycline HCl Capsules, 250 mg       Sandoz, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 61-781               Erythromycin StearateTablets, 250 mg    Do.
----------------------------------------------------------------------------------------------------------------
ANDA 61-965               Nystatin Vaginal Tablets, 100,000       Do.
                           Units
----------------------------------------------------------------------------------------------------------------
ANDA 62-014               Oxytetracycline Capsules, 250 mg        Do.
----------------------------------------------------------------------------------------------------------------
ANDA 62-065               Nystatin Tablets, 500,000 Units         Do.
----------------------------------------------------------------------------------------------------------------

[[Page 42457]]

ANDA 62-590               Kefurox (cefuroxime for injection       Eli Lilly & Co., Lilly Corporate Center,
                           USP), 750 mg/vial and 1.5 g/vial        Indianapolis, IN 46285
----------------------------------------------------------------------------------------------------------------
ANDA 62-592               Kefurox (cefuroxime for injection       Do.
                           USP), 750 mg/vial and 1.5 g/vial
----------------------------------------------------------------------------------------------------------------
ANDA 64-033               Cefazolin Sodium ADD-Vantage Powder     GlaxoSmithKline, One Franklin Plaza, P.O. Box
                           for Injection Solution                  7929, Philadelphia, PA 19101-7929
----------------------------------------------------------------------------------------------------------------
ANDA 65-210               Clarithromycin Extended-Release         Ranbaxy, Inc., U.S. Agent for Ranbaxy
                           Tablets, 1,000 mg                       Laboratories Limited, 600 College Rd. East,
                                                                   Princeton, NJ 08540
----------------------------------------------------------------------------------------------------------------
ANDA 73-696               Nitrofurantoin Capsules USP, 25 mg, 50  Watson Laboratories, Inc., P.O. Box 450 39 Mt.
                           mg, and 100 mg                          Ebo Rd. South, Brewster, NY 10509
----------------------------------------------------------------------------------------------------------------
ANDA 74-648               Lorazepam Oral Solution, 0.5 mg/5 mL    Roxane Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 74-764               Ranitidine Injection USP                Bedford Laboratories, A division of Ben Venue
                                                                   Laboratories, Inc., 300 Northfield Rd.,
                                                                   Bedford, OH 44146
----------------------------------------------------------------------------------------------------------------
ANDA 75-170               Butorphanlol Tartrate Injection USP, 1  Hospira, Inc., 275 N. Field Dr., Dept. 0389,
                           mg/mL and 2 mg/mL                       Bldg. H2, Lake Forest, IL 60045-5046
----------------------------------------------------------------------------------------------------------------
ANDA 76-027               Tamoxifen Citrate Tablets USP, 10 mg    Roxane Laboratories, Inc.
                           and 20 mg
----------------------------------------------------------------------------------------------------------------
ANDA 76-605               Gabapentin Tablets USP, 600 mg and 800  Do.
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 76-643               Carbidopa and Levodopa Tablets for      Do.
                           Oral Suspension, 10 mg/100 mg, 25 mg/
                           100 mg, and 25 mg/250 mg
----------------------------------------------------------------------------------------------------------------
ANDA 76-663               Carbidopa and Levodopa Extended-        KV Pharmaceutical Co., 2503 South Hanley Rd.,
                           Release Tablets, 50 mg/200 mg           St. Louis, MO 63144
----------------------------------------------------------------------------------------------------------------
ANDA 77-366               Glimepiride Tablets USP, 3 mg and 6 mg  Ranbaxy Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 81-096               Acetaminophen, Aspirin, and Codeine     Mikart, Inc., 1750 Chattahoochee Ave., NW,
                           Phosphate Capsules, 150 mg/180 mg/30    Atlanta, GA 30318
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 81-097               Acetaminophen, Aspirin, and Codeine     Do.
                           Phosphate Capsules, 150 mg/180 mg/60
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 81-226               Hydrocodone Bitartrate and              Do.
                           Acetaminophen Oral Solution, 5 mg/500
                           mg/15 mL
----------------------------------------------------------------------------------------------------------------
ANDA 83-902               Dexedrine (dextroamphetamine sulfate),  GlaxoSmithKline, Research Triangle Park, NC
                           5 mg/mL                                 27709-3398
----------------------------------------------------------------------------------------------------------------
ANDA 84-353               Bethanechol Chloride Tablets, 5 mg      Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-378               Bethanechol Chloride Tablets, 10 mg     Do.
                           (Blue)
----------------------------------------------------------------------------------------------------------------
ANDA 84-379               Bethanechol Chloride Tablets, 10 mg     Do.
                           (Pink)
----------------------------------------------------------------------------------------------------------------
ANDA 84-383               Bethanechol Chloride Tablets, 25 mg     Do.
                           (Yellow)
----------------------------------------------------------------------------------------------------------------
ANDA 84-384               Bethanechol Chloride Tablets, 25 mg     Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-617               Hydralazine HCl and Reserpine Tablets,  Do.
                           25 mg/0.1 mg
----------------------------------------------------------------------------------------------------------------
ANDA 84-773               Prednisolone Tablets, 5 mg              Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-774               Prednisone Tablets, 5 mg                Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-869               Imipramine HCl Tablets, 25 mg           Do.
----------------------------------------------------------------------------------------------------------------
ANDA 84-876               Hydrochlorothiazide, Reserpine, and     Do.
                           Hydralazine HCl Tablets, 15 mg/0.1 mg/
                           25 mg
----------------------------------------------------------------------------------------------------------------
ANDA 84-935               Dexedrine (dextroamphetamine sulfate)   GlaxoSmithKline, Research Triangle Park, NC
                           Tablets                                 27709-3398
----------------------------------------------------------------------------------------------------------------
ANDA 84-956               Hydralazine HCl Tablets, 25 mg          Sandoz, Inc.
----------------------------------------------------------------------------------------------------------------

[[Page 42458]]

ANDA 85-088               Hydralazine HCl Tablets, 50 mg          Do.
----------------------------------------------------------------------------------------------------------------
ANDA 85-146               Promethazine HCl Tablets, 25 mg and 50  Do.
                           mg
----------------------------------------------------------------------------------------------------------------
ANDA 85-934               Butabarbital Sodium Tablets, 30 mg      Do.
----------------------------------------------------------------------------------------------------------------
ANDA 85-938               Butabarbital Sodium Tablets, 15 mg      Do.
----------------------------------------------------------------------------------------------------------------
ANDA 86-171               Trichlormethiazide Tablets, 4 mg        Do.
----------------------------------------------------------------------------------------------------------------
ANDA 86-505               Hypaque-76 (diatrizoate meglumine and   GE Healthcare, Inc.
                           diatrizoate sodium injection USP)
----------------------------------------------------------------------------------------------------------------
ANDA 87-118               Chlorthalidone Tablets, 50 mg           Sadoz, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 87-282               Methocarbamol Tablets, 750 mg           Do.
----------------------------------------------------------------------------------------------------------------
ANDA 87-283               Methocarbamol Tablets, 500 mg           Do.
----------------------------------------------------------------------------------------------------------------
ANDA 87-449               Theophylline Oral Solution, 80 mg/15    Roxane Laboratories, Inc.
                           mL
----------------------------------------------------------------------------------------------------------------
ANDA 87-462               Theophylline Extended-Release           Sandoz, Inc.
                           Capsules, 260 mg
----------------------------------------------------------------------------------------------------------------
ANDA 88-157               Chlorpromazine HCl Intensol             Roxane Laboratories, Inc.
                           (chlorpromazine HCl oral concentrate
                           USP), 30 mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 88-158               Chlorpromazine HCl Intensol             Do.
                           (chlorpromazine HCl oral concentrate
                           USP), 100 mg/mL
----------------------------------------------------------------------------------------------------------------
ANDA 88-193               Triprolidine HCl and Pseudoephedrine    Sandoz, Inc.
                           HCl Tablets, 2.5 mg/60 mg
----------------------------------------------------------------------------------------------------------------
ANDA 88-587               Hydrochlorothiazide Oral Solution       Roxane Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 89-127               Mepro-Aspirin (aspirin and              Sandoz, Inc.
                           meprobamate) Tablets, 325 mg/200 mg
----------------------------------------------------------------------------------------------------------------
ANDA 89-508               Fluorouracil Injection USP, 50 mg/mL    Bedford 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.

    Dated: June 15, 2010.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-17785 Filed 7-20-10; 8:45 am]
BILLING CODE 4160-01-S