[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34940-34944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0222]


Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug 
Applications and 52 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 65 new drug applications (NDAs) and 52 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be withdrawn.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 June 16, 2006.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
the table in this document have informed FDA that these drug products 
are no longer marketed and have requested that FDA withdraw approval of 
the applications. The applicants have also, by their requests, waived 
their opportunity for a hearing.

------------------------------------------------------------------------
 Application
     No.                  Drug                       Applicant
------------------------------------------------------------------------
NDA 1-645      Vitamin B6 (pyridoxine      Merck & Co., Inc., 770
                hydrochloride (HCl))        Sumneytown Pike, P.O. Box 4,
                                            BLA-20, West Point, PA 19486-
                                            0004
------------------------------------------------------------------------
NDA 5-521      Heparin Sodium Injection    Eli Lilly and Co., Lilly
                USP                         Corporate Center,
                                            Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 5-657      Tubocurarine Chloride       Bristol-Myers Squibb Co.,
                Injection USP               P.O. Box 4500, Princeton, NJ
                                            08543-4500
------------------------------------------------------------------------
NDA 5-794      Sultrin Triple Sulfa Cream  Ortho-McNeil Pharmaceutical,
                and Triple Sulfa Tablets    Inc., 1000 U.S. Highway 202,
                                            P.O. Box 300, Raritan, NJ
                                            08869-0602
------------------------------------------------------------------------
NDA 6-012      Folvron (folic acid and     Lederle Laboratories, 401
                iron)                       North Middleton Rd., Pearl
                                            River, NY 10965
------------------------------------------------------------------------
NDA 7-149      Rubramin (cyanocobalamin)   Bristol-Myers Squibb Co.
                Tablets and Capsules
------------------------------------------------------------------------
NDA 7-504      Acthar (corticotropin for   Aventis Pharmaceuticals,
                injection)                  Inc., 200 Crossing Blvd., BX
                                            2-309E, Bridgewater, NJ
                                            08807
------------------------------------------------------------------------
NDA 7-794      Neothylline (dyphylline)    Teva Pharmaceuticals USA,
                                            1090 Horsham Rd., P.O. Box
                                            1090, North Wales, PA 19454
------------------------------------------------------------------------
NDA 9-176      Cortril (hydrocortisone)    Pfizer Global
                Topical Ointment            Pharmaceuticals, 235 East
                                            42nd St., New York, NY 10017
------------------------------------------------------------------------
NDA 10-028     Equanil (meprobamate)       Wyeth Pharmaceuticals, P.O.
                Tablets                     Box 8299, Philadelphia, PA
                                            19101-8299
------------------------------------------------------------------------
NDA 10-093     Biphetamine                 Celltech Pharmaceuticals,
                (dextroamphetamine and      Inc., 755 Jefferson Rd.,
                amphetamine) Capsules       P.O. Box 31710, Rochester,
                                            NY 14603
------------------------------------------------------------------------
NDA 10-513     Ketonil (amino acids and    Merck & Co., Inc.
                electrolytes)
------------------------------------------------------------------------
NDA 10-787     Iron Dextran Injection      Aventis Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 10-799     Dimetane (brompheniramine   Wyeth Consumer Healthcare, 5
                maleate) Tablets and        Giralda Farms, Madison, NJ
                Extendtabs                  07940
------------------------------------------------------------------------
NDA 11-340     Cerumenex (triethanolamine  The Purdue Frederick Co., 1
                polypeptide oleate-         Stamford Forum, Stamford, CT
                condensate), 10%            06901-3431
------------------------------------------------------------------------

[[Page 34941]]

 
NDA 11-960     Aristocort (triamcinolone   Astellas Pharma US, Inc., 3
                diacetate) Syrup            Parkway North, Deerfield, IL
                                            60015-2548
------------------------------------------------------------------------
NDA 11-984     Decadron Phosphate          Merck & Co., Inc.
                (dexamethasone sodium
                phosphate) Sterile
                Ophthalmic Solution
------------------------------------------------------------------------
NDA 12-122     Glucagon (glucagon HCl)     Eli Lilly & Co.
                for Injection
------------------------------------------------------------------------
NDA 12-281     Robaxisal (methocarbamol    A.H. Robins Co., c/o Wyeth
                USP and aspirin USP)        Pharmaceuticals, P.O. Box
                Tablets                     8299, Philadelphia, PA 19101-
                                            8299
------------------------------------------------------------------------
NDA 12-649     Periactin (cyproheptadine   Merck & Co., Inc.
                HCl)
------------------------------------------------------------------------
NDA 12-703     Elavil (amitriptyline HCl)  AstraZeneca Pharmaceuticals,
                Tablets                     1800 Concord Pike, P.O. Box
                                            8355, Wilmington, DE 19803-
                                            8355
------------------------------------------------------------------------
NDA 12-704     Elavil (amitriptyline HCl)  Do.
                Injection
------------------------------------------------------------------------
NDA 13-220     Periactin (cyproheptadine   Merck & Co., Inc.
                HCl) Syrup, 2 milligrams
                (mg)/5 milliliters (mL)
------------------------------------------------------------------------
NDA 13-400     Aldomet (methyldopa)        Do.
                Tablets
------------------------------------------------------------------------
NDA 13-401     Aldomet (methyldopate HCl)  Do.
                Injection, 50 mg/mL
------------------------------------------------------------------------
NDA 13-413     Dexacort Phosphate          Celltech Pharmaceuticals,
                (dexamethasone sodium       Inc.
                phosphate) in Respihaler
------------------------------------------------------------------------
NDA 16-016     Aldoclor-150 and -250       Merck & Co., Inc.
                (methyldopa and
                chlorothiazide) Tablets,
                250 mg/150 mg and 250 mg/
                250 mg
------------------------------------------------------------------------
NDA 16-030     Bayer 8 Hour Aspirin and    Bayer Healthcare, LLC, 36
                Measurin Aspirin (aspirin   Columbia Rd., P.O. Box 1910,
                extended-release            Morristown, NJ 07962-1910
                tablets), 650 mg
------------------------------------------------------------------------
NDA 16-099     Atromid-S (clofibrate)      Wyeth Pharmaceuticals
                Capsules
------------------------------------------------------------------------
NDA 16-745     Jergens Antibacterial       Kao Brands Co., 2535 Springs
                Deodorant (triclocarban,    Grove Ave., Cincinnati, OH
                1%) Soap                    45214-1773
------------------------------------------------------------------------
NDA 16-888     Selsun Blue (selenium       Abbott Laboratories, 625
                sulfide) Cream/Shampoo,     Cleveland Ave., Columbus, OH
                1%                          43215-1724
------------------------------------------------------------------------
NDA 17-569     Renoquid (sulfacytine)      Glenwood LLC, 111 Cedar Lane,
                Tablets                     Englewood, NJ 07631
------------------------------------------------------------------------
NDA 17-573     Vanceril (beclomethasone    Schering Corp., 2000
                dipropionate) Inhalation    Galloping Hill Rd.,
                Aerosol                     Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 17-659     Alupent (metaproterenol     Boehringer Ingelheim
                sulfate) Inhalation         Pharmaceuticals, Inc., 900
                Solution, 5%                Ridgebury Rd., P.O. Box 368,
                                            Ridgefield, CT 06877-0368
------------------------------------------------------------------------
NDA 17-781     Diprosone (betamethasone    Schering Corp.
                dipropionate) Lotion
------------------------------------------------------------------------
NDA 17-820     Dobutrex (dobutamine HCl)   Eli Lilly & Co.
                Sterile Injection
------------------------------------------------------------------------
ANDA 18-023    Lactated Ringer's           B. Braun Medical, Inc., 2525
                Injection USP               McGaw Ave., P.O. Box 19791,
                                            Irvine, CA 92623-9791
------------------------------------------------------------------------
ANDA 18-026    5% Dextrose and 0.9%        Do.
                Sodium Chloride (NaCl)
                Injection
------------------------------------------------------------------------
ANDA 18-046    10% Dextrose Injection USP  Do.
------------------------------------------------------------------------
ANDA 18-047    10% Dextrose and 0.9% NaCl  Do.
                Injection USP
------------------------------------------------------------------------
ANDA 18-184    0.45% NaCl Injection USP    Do.
------------------------------------------------------------------------
ANDA 18-186    1/6 Molar Sodium Lactate    Do.
                Injection USP in Plastic
                Container
------------------------------------------------------------------------
ANDA 18-197    Ibuprofen Tablets           BASF Corp., 8800 Line Ave.,
                                            Shreveport, LA 71106
------------------------------------------------------------------------
ANDA 18-252    Isolyte S (multi-           B. Braun Medical, Inc.
                electrolyte injection)
                Injection
------------------------------------------------------------------------
ANDA 18-256    5% Dextrose in Ringer's     Do.
                Injection
------------------------------------------------------------------------
NDA 18-257     Tonocard (tocainide HCl)    AstraZeneca Pharmaceuticals
                Tablets, 400 mg and 600
                mg
------------------------------------------------------------------------

[[Page 34942]]

 
ANDA 18-274    Isolyte S (multi-           B. Braun Medical, Inc.
                electrolyte injection)
                with 5% Dextrose in
                Plastic Container
------------------------------------------------------------------------
NDA 18-389     Aldomet (methyldopa) Oral   Merck & Co., Inc.
                Suspension, 250 mg/5 mL
------------------------------------------------------------------------
NDA 18-682     TZ-3 (1% tioconazole)       Pfizer, Inc., 235 East 42nd
                Dermal Cream                St., New York, NY 10017
------------------------------------------------------------------------
NDA 18-686     Normodyne (labetalol HCl    Schering Corp.
                USP) Injection, 5 mg/mL
------------------------------------------------------------------------
NDA 18-687     Normodyne (labetalol HCl    Do.
                USP) Tablets
------------------------------------------------------------------------
ANDA 18-721    Ringer's Injection USP      B. Braun Medical, Inc.
------------------------------------------------------------------------
NDA 18-754     Orudis (ketoprofen)         Wyeth Pharmaceuticals
                Capsules, 25 mg, 50 mg,
                and 75 mg
------------------------------------------------------------------------
NDA 18-792     Neopham (amino acids)       Hospira, Inc., 275 North
                Injection                   Field Dr., Dept. 389, Bldg.
                                            2, Lake Forest, IL 60045
------------------------------------------------------------------------
NDA 18-901     Aminess (essential amino    Do.
                acids injection with
                histidine)
------------------------------------------------------------------------
NDA 18-911     Heparin Sodium in 5%        Do.
                Dextrose Injection and
                Heparin Sodium in NaCl
                Injection
------------------------------------------------------------------------
NDA 19-083     Theophylline and 5%         B. Braun Medical, Inc.
                Dextrose Injection
------------------------------------------------------------------------
NDA 19-107     Protropin (somatrem) for    Genentech, Inc., 1 DNA Way
                Injection                   MS242, South San
                                            Francisco, CA 94080-4990
------------------------------------------------------------------------
ANDA 19-138    Alphatrex (betamethasone    Savage Laboratories, 60
                dipropionate cream USP)     Baylis Rd., Melville, NY
                0.05%                       11747
------------------------------------------------------------------------
ANDA 19-143    Alphatrex (betamethasone    Do.
                dipropionate ointment
                USP) 0.05%
------------------------------------------------------------------------
NDA 19-383     Proventil (albuterol        Schering Corp.
                sulfate extended-release
                tablets USP) Repetabs
------------------------------------------------------------------------
NDA 19-401     Pseudo-12 Suspension        Celltech Pharmaceuticals,
                (pseudoephedrine            Inc.
                polistirex extended-
                release suspension)
------------------------------------------------------------------------
NDA 19-523     Cysteine HCl Injection      Hospira, Inc.
                USP, 7.25%
------------------------------------------------------------------------
NDA 19-589     Vancenase AQ                Schering Corp.
                (beclomethasone
                dipropionate) Nasal Spray
------------------------------------------------------------------------
NDA 19-621     Ventolin (albuterol         GlaxoSmithKline
                sulfate) Syrup              Pharmaceuticals, 5 More Dr.,
                                            P.O. Box 13358, Research
                                            Triangle Park, NC 27709
------------------------------------------------------------------------
NDA 20-035     Ergamisol (levamisole HCl)  Johnson & Johnson
                Tablets                     Pharmaceutical Research and
                                            Development, LLC, c/o
                                            Janssen Pharmaceutical
                                            Products, LP, 1125 Trenton-
                                            Harbourton Rd., K1-02B,
                                            Titusville, NJ 08560-0200
------------------------------------------------------------------------
NDA 20-176     VitaPed (multivitamins)     Hospira, Inc.
------------------------------------------------------------------------
NDA 20-338     Differin (adapalene)        Galderma Laboratories, LP,
                Solution, 0.1%              14501 North Freeway, Fort
                                            Worth, TX 76177
------------------------------------------------------------------------
NDA 20-759     Trovan (trovafloxacin       Pfizer, Inc.
                mesylate) Tablets, 100 mg
                and 200 mg
------------------------------------------------------------------------
NDA 20-760     Trovan (alatrofloxacin      Do.
                mesylate) Injection
------------------------------------------------------------------------
NDA 20-847     Esclim (estradiol extended- Women First Healthcare, Inc.,
                release film) Transdermal   380 Lexington Ave., New
                System                      York, NY 10168
------------------------------------------------------------------------
NDA 20-962     Emla (2.5% lidocaine and    AstraZeneca Pharmaceuticals
                2.5% prilocaine)
                Anesthetic Disc
------------------------------------------------------------------------
ANDA 40-023    Adrucil (fluorouracil       Sicor Pharmaceuticals, Inc.,
                injection USP), 50 mg/mL    19 Hughes, Irvine, CA 92618
------------------------------------------------------------------------
ANDA 40-147    Leucovorin Calcium          Hospira, Inc.
                Injection USP, 10 mg
                (base)/mL
------------------------------------------------------------------------
NDA 50-039     Garamycin (gentamicin       Schering Corp.
                sulfate) Ophthalmic
                Solution
------------------------------------------------------------------------

[[Page 34943]]

 
NDA 50-091     Chloroptic                  Allergan, Inc., 2525 Dupont
                (chloramphenicol            Dr., P.O. Box 19534, Irvine,
                ophthalmic solution USP),   CA 92623-9534
                0.5%
------------------------------------------------------------------------
NDA 50-322     Neodecadron (neomycin       Merck & Co., Inc.
                sulfate and dexamethasone
                sodium phosphate) Sterile
                Ophthalmic Solution
------------------------------------------------------------------------
NDA 50-368     Ilotycin (erythromycin)     Eli Lilly & Co.
                Ophthalmic Ointment
------------------------------------------------------------------------
NDA 50-571     CefMax (cefmenoxime HCl)    TAP Pharmaceutical Products,
                Injection                   Inc., 675 North Field Dr.,
                                            Lake Forest, IL 60045
------------------------------------------------------------------------
NDA 50-648     Clindamycin Phosphate       Baxter Healthcare Corp.,
                Injection in 5% Dextrose    Route 120 & Wilson Rd.,
                                            Round Lake, IL 60073
------------------------------------------------------------------------
ANDA 60-429    Sumycin Capsules            Apothecon, c/o Bristol-Myers
                (tetracycline HCl           Squibb Co., P.O. Box 4500,
                capsules USP)               Princeton, NJ 08543-4500
------------------------------------------------------------------------
ANDA 62-480    Gentacidin Solution         Novartis Pharmaceuticals
                (gentamicin sulfate         Corp., 1 Health Plaza, Bldg.
                ophthalmic solution USP)    118, East Hanover, NJ 07936-
                                            1080
------------------------------------------------------------------------
ANDA 62-597    Mytrex (nystatin and        Savage Laboratories
                triamcinolone acetonide
                cream USP) 100,000 units/
                gram (g) and 1 mg/g
------------------------------------------------------------------------
ANDA 62-601    Mytrex (nystatin and        Do.
                triamcinolone acetonide
                ointment USP) 100,000
                units/g and 1 mg/g
------------------------------------------------------------------------
ANDA 62-750    Pipracil (piperacillin for  Wyeth Pharmaceuticals, Inc.
                injection), 2 g, 3 g, and
                4 g
------------------------------------------------------------------------
ANDA 63-186    Cephalexin Capsules USP,    Apothecon, c/o Bristol-Myers
                250 mg and 500 mg           Squibb Co.
------------------------------------------------------------------------
ANDA 64-084    Sterile Bleomycin Sulfate   Sicor Pharmaceuticals, Inc.
                for Injection USP, 15 and
                30 units/vial
------------------------------------------------------------------------
ANDA 70-083    Ibuprofen Tablets USP, 400  BASF Corp.
                mg
------------------------------------------------------------------------
ANDA 70-099    Ibuprofen Tablets USP, 600  Do.
                mg
------------------------------------------------------------------------
ANDA 70-273    Alphatrex (betamethasone    Savage Laboratories
                dipropionate lotion USP),
                0.05%
------------------------------------------------------------------------
ANDA 70-745    Ibuprofen Tablets USP, 800  BASF Corp.
                mg
------------------------------------------------------------------------
ANDA 72-621    Acetylcysteine Solution     Roxane Laboratories, Inc.,
                USP, 10%                    P.O. Box 16532, Columbus, OH
                                            43216
------------------------------------------------------------------------
ANDA 72-622    Acetylcysteine Solution     Do.
                USP, 20%
------------------------------------------------------------------------
ANDA 72-995    Metoclopramide HCl Oral     Do.
                Solution, 10 mg/mL
------------------------------------------------------------------------
ANDA 73-562    Diflunisal Tablets USP,     Do.
                250 mg
------------------------------------------------------------------------
ANDA 73-563    Diflunisal Tablets USP,     Do.
                500 mg
------------------------------------------------------------------------
ANDA 74-166    Toposar (etoposide          Sicor Pharmaceuticals, Inc.
                injection USP), 20 mg/mL
------------------------------------------------------------------------
ANDA 74-541    Cimetidine HCl Oral         Roxane Laboratories, Inc.
                Solution, 30 mg/5 mL
------------------------------------------------------------------------
ANDA 74-663    Acyclovir Sodium for        Hospira, Inc.
                Injection USP, 500 mg
                base/vial and 1 g base/
                vial
------------------------------------------------------------------------
ANDA 75-179    Nabumetone Tablets          Copley Pharmaceutical, Inc.,
                                            1090 Horsham Rd., P.O. Box
                                            1090, North Wales, PA 19454
------------------------------------------------------------------------
ANDA 75-875    Carbamazepine Oral          Taro Pharmaceutical
                Suspension USP, 100 mg/5    Industries, Ltd., c/o Taro
                mL                          Pharmaceuticals, U.S. Agent,
                                            5 Skyline Dr., Hawthorne, NY
                                            10532
------------------------------------------------------------------------
ANDA 80-643    Diphenhydramine HCl Elixir  Roxane Laboratories, Inc.
                USP, 25 mg/10 mL
------------------------------------------------------------------------
ANDA 81-225    Adrucil (etopside           Sicor Pharmaceuticals, Inc.
                injection USP), 50 mg/mL
------------------------------------------------------------------------
ANDA 83-261    Pentobarbital Sodium        Wyeth Pharmaceuticals
                Injection USP
------------------------------------------------------------------------
ANDA 83-383    Diucardin                   Do.
                (hydroflumethiazide
                tablets USP) Tablets, 50
                mg
------------------------------------------------------------------------

[[Page 34944]]

 
ANDA 84-015    Bleph-10 (sulfacetamide     Allergan, Inc.
                sodium ophthalmic
                ointment USP) Ophthalmic
                Ointment, 10%
------------------------------------------------------------------------
ANDA 84-514    Dilor (dyphylline tablets   Savage Laboratories
                USP), 200 mg
------------------------------------------------------------------------
ANDA 84-751    Dilor-400 (dyphylline       Do.
                tablets USP), 400 mg
------------------------------------------------------------------------
ANDA 85-035    Diphenoxylate HCl and       R & S Pharma, LLC, 8407
                Atropine Sulfate Tablets    Austin Tracy Rd., Fountain
                USP, 2.5 mg and 0.025 mg    Run, KY 42133
------------------------------------------------------------------------
ANDA 85-961    Methocarbamol Tablets USP,  Clonmel Healthcare Ltd., c/o
                500 mg                      STADA Pharmaceuticals, Inc.,
                                            U.S. Agent, 5 Cedar Brook
                                            Dr., Cranbury, NJ 08512
------------------------------------------------------------------------
ANDA 85-963    Methocarbomal Tablets USP,  Do.
                750 mg
------------------------------------------------------------------------
ANDA 86-899    Isoetharine HCl Inhalation  Roxane Laboratories, Inc.
                Solution USP, 1%
------------------------------------------------------------------------
ANDA 87-450    Chlorthalidone Tablets      Clonmel Healthcare Ltd.
                USP, 50 mg
------------------------------------------------------------------------
ANDA 87-451    Chlorthalidone Tablets      Do.
                USP, 25 mg
------------------------------------------------------------------------
ANDA 87-500    Aminophylline Tablets USP,  Roxane Laboratories, Inc.
                100 mg
------------------------------------------------------------------------
ANDA 87-501    Aminophylline Tablets USP,  Do.
                200 mg
------------------------------------------------------------------------
ANDA 88-253    T-Phyl (theophylline)       The Purdue Frederick Co.
                Extended-Release Tablets,
                200 mg
------------------------------------------------------------------------

    Therefore, under section 505(e), of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)), and under authority delegated to the 
Director, Center for Drug Evaluation and Research, by the Commissioner 
of Food and Drugs, approval of the applications listed in the table in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective June 16, 2006.

    Dated: May 23, 2006.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E6-9440 Filed 6-15-06; 8:45 am]
BILLING CODE 4160-01-S