[Federal Register Volume 66, Number 23 (Friday, February 2, 2001)]
[Notices]
[Pages 8801-8805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2790]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1198]


John J. Ferrante et al; Withdrawal of Approval of 125 Abbreviated 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 125 abbreviated new drug applications (ANDA's). The basis for the 
withdrawals is that the holders of the applications have repeatedly 
failed to file required annual reports for these applications.

DATES: Effective February 2, 2001.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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 approved applications to 
market new drugs for human use are required to submit annual reports to 
FDA concerning each of their approved applications in accordance with 
Sec. 314.81 (21 CFR 314.81).
    In the Federal Register of March 28, 2000 (65 FR 16397), FDA 
offered an opportunity for a hearing on a proposal to withdraw approval 
of 158 ANDA's because the firms had failed to submit the required 
annual reports for these applications.

I. Annual Reports Submitted

    In response to the notice of opportunity for a hearing (NOOH), 5

[[Page 8802]]

firms requested hearings and submitted an annual report for each of 18 
ANDA's. Therefore, FDA rescinds its proposal to withdraw approval of 
the following 18 ANDA's:
    1. Ambix Laboratories, 210 Orchard St., East Rutherford, NJ 07073; 
ANDA 60-453, Neomycin and Polymyxin B Sulfate and Bacitracin Ointment 
with Diperodon Hydrochloride (HCl).
    2. Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, 
MI 48220; ANDA 81-008, Chlorzoxazone Tablets USP, 500 milligrams (mg).
    3. Hygenics Pharmaceuticals, Inc., 26941 Cabot Rd., suite 128, 
Laguna Hills, CA 92653; ANDA 71-419, Chlorhexidine Gluconate Topical 
Solution, 4%.
    4. Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd., Charlotte, 
NC 28206; ANDA 62-538, Doxycycline Hyclate Tablets USP, 100 mg; ANDA 
71-639, Ibuprofen Tablets USP, 200 mg; ANDA 71-644, Ibuprofen Tablets 
USP, 400 mg; ANDA 89-805, Acetaminophen and Codeine Phosphate Tablets 
USP, 300 mg/30 mg; ANDA 89-828, Acetaminophen and Codeine Phosphate 
Tablets USP, 300 mg/60 mg; and ANDA 89-990, Acetaminophen and Codeine 
Phosphate Tablets USP, 300 mg/15 mg.
    5. Wendt Laboratories, Inc., 100 Nancy Dr., P.O. Box 128, Belle 
Plaine, MN 56011; ANDA 84-185, Bethanechol Chloride Tablets, 10 mg; 
ANDA 84-186, Bethanechol Chloride Tablets, 25 mg; ANDA 85-039, Folic 
Acid Tablets USP, 1 mg; ANDA 85-040, Isoniazed Tablets USP, 100 mg; 
ANDA 85-041, Meclizine HCL Tablets, 25 mg; ANDA 85-042, Methocarbamol 
Tablets USP, 500 mg; ANDA 85-044, Reserpine Tablets USP, 0.25 mg; ANDA 
86-766, Nitrofurazone Ointment, 0.2%; and ANDA 87-081, Nitrofurazone 
Solution, 0.2%.

II. Requests to Withdraw Approval

    In response to the NOOH, Zenith Goldline Pharmaceuticals, Inc., 140 
Legrand Ave., Northvale, NJ 07647 notified the agency that they no 
longer market the products for ANDA's 83-682, 85-539, 85-733, 85-777, 
87-328, 87-375, 87-376, 87-377, 87-427, 87-428, 87-429, 87-430, 87-612, 
87-613, and 87-614. In the Federal Register of October 2, 2000 (65 FR 
58775), the agency withdrew approval of these 15 ANDA's under the 
written request of the applicant.
    Another 7 firms notified the agency that they no longer market the 
products for 14 of the ANDA's listed in the NOOH. The firms did not 
request hearings and submitted formal requests for the agency to 
withdraw approval of the ANDA's for these products. These 14 ANDA's are 
included in the table in this notice and are marked with a footnote.

III. No Response to NOOH Received

    The holders of the other 111 applications did not respond to the 
NOOH. Failure to file a written notice of participation and request for 
hearing as required by 21 CFR 314.200 constitutes an election by the 
applicant not to make use of the opportunity for a hearing concerning 
the proposal to withdraw approval of the applications and a waiver of 
any contentions concerning the legal status of the drug products.
    Therefore, the Director, Center for Drug Evaluation and Research, 
is withdrawing approval of the applications listed in the table of this 
document.

 
------------------------------------------------------------------------
  ANDA
  No.                Drug                          Applicant
------------------------------------------------------------------------
60-058   Chloramphenicol Capsules,    John J. Ferrante, c/o Operations
          250 mg.                      Management Consulting, 11 Fairway
                                       Lane, Trumbull, CT 06611.
60-062   Penicillin G Potassium.      The Upjohn Co., 700 Portage Rd.,
                                       Kalamazoo, MI 49001.
60-094   Sterile Penicillin G         Do.
          Procaine Suspension USP.
60-110   Sterile Dihydrostreptomycin  Pfizer Central Research, Pfizer,
          Sulfate USP.                 Inc., Eastern Point Rd., Groton,
                                       CT 06340.
60-170   Penicillin G Potassium       John J. Ferrante.
          Tablets, 200,000, 250,000,
          and 400,000 units.
60-173   Tetracycline HCl Capsules,   Do.
          250 mg.
60-174   Tetracycline Oral            Do.
          Suspension, 125 mg/5
          milliliters (ml).
60-177   Bacitracin-Neomycin Sulfate  Do.
          Polymyxin B Sulfate
          Ointment.
60-178   Bacitracin-Neomycin Sulfate  Do.
          Ointment.
60-179   Oxytetracycline HCl          Do.
          Capsules, 250 mg.
60-188\  Neomycin Sulfate and         Akorn, Inc., c/o Walnut
 1\       Hydrocortisone Acetate       Pharmaceuticals, Inc., 1340 North
          Ophthalmic Suspension USP.   Jefferson St., Anaheim, CA 92807.
60-360   Neomycin and Polymyxin B     Ambix Laboratories, 210 Orchard
          Sulfate and Bacitracin       St., East Rutherford, NJ 07073.
          with Benzocaine.
60-435   Tetracycline HCl Tablets     Farmitalia Carlo Erba S.p.A., c/o
          USP, 250 mg.                 Montedison, USA, Inc., 1114
                                       Avenue of the Americas, New York,
                                       NY 10036.
60-464   Neomycin Sulfate and         The Upjohn Co.
          Prednisolone.
60-647   Neo-Polycin Ophthalmic       Merrell Dow Pharmaceuticals, Inc.,
          Ointment.                    P.O. Box 68511, Indianapolis, IN
                                       46268.
60-666   Ampicillin Tihydrate for     Beecham Laboratories, 501 Fifth
          Oral Suspension.             St., Bristol, TN 37620.
60-690   Oxytetracycline HCl.         Pierrel America, Inc., 576 Fifth
                                       Ave., New York, NY 10036.
60-720   Tetracycline HCl Capsules,   Towne Paulsen & Co., Inc., 140
          250 mg.                      East Duarte Rd., Monrovia, CA
                                       91016.
60-757   Polymyxin B Sulfate,         Burroughs Wellcome Co., 3030
          500,000 units.               Cornwallis Rd., Research Triangle
                                       Park, NC 27709.
60-774   Griseofulvin Tablets, 500    McNeil Consumer, Inc., Camp Hill
          mg.                          Rd., Fort Washington, PA 19034.
60-809   Penicillin G Potassium       Consolidated Pharmaceutical Group,
          Tablets USP, 100,000,        6110 Robinwood Rd., Baltimore, MD
          200,000, 250,000, 400,000,   21225.
          and 500,000 units.
60-855   Oxytetracycline HCl          Rachelle Laboratories, Inc., 700
          Capsules, 250 mg.            Henry Ford Ave., P.O. Box 2029,
                                       Long Beach, CA 90801.
60-869   Oxytetracycline HCl          Proter S.p.A., c/o Arnold Buhl
          Capsule, 250 mg.             Christen, 1000 Connecticut Ave.,
                                       Washington, DC 20086.
61-174   Candicidin.                  Penick Corp., 1050 Wall St. West,
                                       Lyndhurst, NJ 07071.

[[Page 8803]]

 
61-396   Hetacillin Capsules.         Bristol-Myers, U.S. Pharmaceutical
                                       Group, Evansville, IN 47721-
                                       0001.
61-523\  Tetracycline HCl             Lederle Laboratories, Division of
 1\       Susceptibility Powder, 20    American Cyanamid Co., Pearl
          mg.                          River, NY 10965.
61-676   Ampicillin Trihydrate        Public Health Service, Health
          Capsules, 250 mg and 500     Service Administration, Perry
          mg.                          Point, MD 21902.
61-700\  Bacitracin Zinc USP for      Alpharma A. S., One Executive Dr.,
 1\       Compounding.                 P.O. Box 1399, Fort Lee, NJ
                                       07024.
61-718   Nystatin Vaginal Tablets     Holland-Rantos Co., Inc., 310
          USP, 100,000 units.          Enterprise Ave., Trenton, NJ
                                       08638.
61-720   Doxycycline Oral Suspension  Rachelle Laboratories, Inc.
          USP.
61-933   Penicillin G Potassium for   E. R. Squibb & Sons, P.O. Box 191,
          Injection USP.               New Brunswick, NJ 08903-0191.
61-953   Doxycycline Hyclate          Rachelle Laboratories, Inc., P.O.
          Injection.                   Box 187, Culver, IN 46511.
61-957   Benzylpenicilloyl            Kremers-Urban Co., 5600 West
          Polylysine Injection.        County Line Rd., P.O. Box 2038,
                                       Milwaukee, WI 53201.
61-961\  Bacitracin Ointment USP.     Clay-Park Labs, Inc., 1700
 1\                                    Bathgate Ave., Bronx, NY 10457.
61-994   Kanamycin Sulfate Injection  Bristol Laboratories, Division of
          USP.                         Bristol-Myers Co., P.O. Box 657,
                                       Syracuse, NY 13201.
62-007\  Bacitracin USP, 50,000 and   Alpharma A. S.
 1\       10,000 units/vial.
62-042\  Chloramphenicol Ophthalmic   Akorn, Inc.
 1\       Solution, 0.5%.
62-138   Cefoxitin Solution.          Pfizer Pharmaceuticals, Inc., 235
                                       East 42d St., New York, NY 10017.
62-224   Neomycin Sulfate Ointment.   Clay-Park Labs, Inc.
62-236   Bacitracin Ointment USP.     Denison Laboratories, Inc., 60
                                       Dunnell Lane, P.O. Box 1305,
                                       Pawtucket, RI 02862.
62-248   Gentamicin Sulfate           The Upjohn Co.
          Injection USP.
62-345   Tetracycline HCl Capsules,   Public Health Service, HAS Supply
          250 mg.                      Service Center, Perry Point, MD
                                       21902.
62-354   Gentamicin Sulfate           Kalapharm, Inc., 145 East 27th
          Injection USP.               St., New York, NY 10016.
62-357   Amoxicillin Trihydrate       Public Health Service, HAS Supply
          Capsules, 250 mg and 500     Service Center.
          mg.
62-359   Bacitracin Topical           NMC Laboratories, Inc., 70-36 83d
          Ointment, 500 units/gram.    St., Glendale, NY 11385.
62-361   Bacitracin-Neomycin-         Do.
          Polymyxin B Sulfate.
62-528   Amoxicillin Capsules USP,    Laboratories Atral, S.A., c/o
          250 mg and 500 mg.           Louie F. Turner, P.O. Box 331044,
                                       Fort Worth, TX 76133-2924.
71-278   PEG 3350 and Electrolytes    E-Z-EM, Inc., 717 Main St.,
          for Oral Solution USP.       Westbury, NY 11590.
71-320   PEG 3350 and Electrolytes    DynaPharm, Inc., P.O. Box 2141,
          for Oral Solution USP.       Del Mar, CA 92014.
71-777   Clorazepate Dipotassium      Able Laboratories, 333 Cassell
          Capsules, 3.75 mg.           Dr., suite 3500, Baltimore, MD
                                       21224.
71-778   Clorazepate Dipotassium      Do.
          Capsules, 7.5 mg.
71-779   Clorazepate Dipotassium      Do.
          Capsules, 15 mg.
72-319   Glycoprep (PEG 3350 and      Goldline Laboratories, 1900 West
          Electrolytes for Oral        Commerical Blvd., Ft. Lauderdale,
          Solution).                   FL 33309.
72-399   Sulfamethoxazole and         NASKA Pharmacal Co., Inc., P.O.
          Trimethorprim Oral           Box 898 Riverview Rd.,
          Suspension USP.              Lincolnton, NC 28093.
72-409   Nifedipine Capsules USP, 10  Chase Laboratories, Inc., 280
          mg.                          Chestnut St., Newark, NJ 07105.
73-421   Nifedipine Capsules USP, 20  Do.
          mg.
74-080   Carbidopa and Levodopa       SCS Pharmaceuticals, 4901 Searle
          Tablets USP, 10 mg/100 mg,   Pkwy., Skokie, IL 60077.
          25 mg/100 mg, 25 mg/250
          mg.
80-094   Triple Sulfoid Tablets.      Pal-Pak, Inc., 1201 Liberty St.,
                                       Allentown, PA 18102.
80-117   Nitrofurantoin Tablets, 50   Rachelle Laboratories, Inc., 700
          mg.                          Henry Ford Ave., P.O. Box 2029,
                                       Long Beach, CA 90801.
80-118   Nitrofurantoin Tablets, 100  Do.
          mg.
80-335   Prednisolone Tablets, 5 mg.  Central Pharmaceutical, Inc., 110-
                                       128 East Third St., Seymour, IN
                                       47274.
80-375   Lidocaine HCl Injection      Rachelle Laboratories, Inc.
          USP, 2%.
80-376   Lidocaine HCl Injection      Do.
          USP, 1%.
80-481   Hydrocortisone Ointment      C & M Pharmacal, Inc., 1721 Maple
          USP.                         Lane, Hazel Park, MI 48030-1215.
80-482   Hydrocortisone Cream USP.    Do.
80-562   Prednisolone Tablets, 2.5    John J. Ferrante.
          mg and 5 mg.
80-568   Hydrocortisone Tablets, 10   Do.
          mg and 20 mg.
80-967   Vitamin A Capsules USP.      West-Ward, Inc., 465 Industrial
                                       Lane, Eatontown, NJ 07724.
83-102   Vitamin D Capsules, 50,000   Do.
          units.
83-156   Hydrocortisone Acetate       Parke-Davis, Div. of Warner-
          Cream, 1.0%.                 Lambert Co., 201 Tabor Rd.,
                                       Morris Plains, NJ 07950.
83-161\  Dexamethasone Sodium         Dell Laboratories, Inc., 668 Front
 1\       Phosphate Injection.         St., Teaneck, NJ 07666.
83-358\  Prednisolone Sodium          Akorn, Inc.
 1\       Phosphate Ophthalmic
          Solution USP.
83-400   Propoxyphene HCl Capsules    Rachelle Laboratories, Inc.
          USP, 65 mg.
83-643   Acetaminophen and Codeine    Carnrick Laboratories, Inc., 65
          Phosphate Tablets, 325 mg/   Horse Hill Rd., Cedar Knolls, NJ
          30 mg.                       07927.
83-787   Chlorpheniramine Maleate     West-Ward, Inc.
          Tablets, 4 mg.
83-790   Phendimetrazine Tartrate     Numark Laboratories, Inc., 75
          Tablets USP, 35 mg.          Mayfield Ave., Edison, NJ 08837.

[[Page 8804]]

 
83-791   Nitrofurazone Powder.        Roberts Laboratories, Inc., 4
                                       Industrial Way West, Eatontown,
                                       NJ 07724.
83-829   Chlorpromazine HCl Tablets   Rachelle Laboratories, Inc.
          USP.
83-977   Selenium Sulfide.            USV Pharmaceutical Corp., One
                                       Scarsdale Rd., Tuckahoe, NY
                                       10707.
84-030   Meprobamate Tablets, 400     Ferndale Laboratories, Inc.
          mg.
84-255   Sulfasalazine Tablets, 500   William H. Rorer, Inc., 500
          mg.                          Virginia Dr., Fort Washington, PA
                                       19034.
84-337   Sulfisoxasole Tablets, 500   Rachelle Laboratories, Inc.
          mg.
84-377\  Prednisone Capsules, 50 mg.  R. P. Scherer Corp., 2725 Scherer
 1\                                    Dr., St. Petersburg, FL 33702.
84-492\  Prednisolone Acetate         Akorn, Inc.
 1\       Injection.
84-563   Aminophylline Tablets, 200   ICN Pharmaceuticals, Inc., 5040
          mg.                          Lester Rd., Cincinnati, OH 45213.
84-639   Chlordiazepoxide HCl         Rachelle Laboratories, Inc.
          Capsules USP, 10 mg.
84-727   Lidocaine HCl Injection,     Pharmaton, Inc., 150 East 58th
          2%.                          St., New York, NY 19155.
84-728   Lidocaine HCl Injection, 2%  Pharmaton, Inc., c/o Bass, Ullman
          with Epinephrine 1:50,000.   & Lustrigman, 747 Third Ave., New
                                       York, NY 10017.
84-855\  Dexamethasone Sodium         Akorn, Inc.
 1\       Phosphate Ophthalmic
          Solution USP, 0.1%.
85-086   Chlordiazepoxide HCl         Rachelle Laboratories, Inc.
          Capsules, 5 mg.
85-087   Chlordiazepoxide HCl         Do.
          Capsules USP, 25 mg.
85-091   Isoniazid Tablets USP, 100   Pharmavite Corp., 15451 San
          mg.                          Fernando Mission Blvd., P.O. Box
                                       9606, Mission Hills, CA 91346-
                                       9606.
85-104   Chlorpheniramine Maleate     Do.
          Tablets USP, 4 mg.
85-118   Chlordiazepoxide HCl         John J. Ferrante.
          Capsules, 5 mg.
85-119   Chlordiazepoxide HCl         Do.
          Capsules, 10 mg.
85-120   Chlordiazepoxide HCl         Do.
          Capsules, 25 mg.
85-341   Butabartital Sodium Tablets  Vale Chemical Co., Inc., 1201
          USP, 30 mg.                  Liberty St., Allentown, PA 18102.
85-345   Butabartital Sodium Tablets  Do.
          USP, 15 mg.
85-477   Secobarbital Sodium          ICN Pharmaceuticals, Inc., 222
          Capsules, 100 mg.            North Vincent Ave., Covina, CA
                                       91722.
85-509   Diphenoxylate HCl and        Inwood Laboratories, Inc.,
          Atropine Sulfate Tablets     Subsidiary of Forest Labs, Inc.,
          USP, 2.5 mg/0.025 mg.        150 East 58th St., New York, NY
                                       10155.
85-630   Trichlormethiazide Tablets,  Lannett Co., Inc., 9000 State Rd.,
          4 mg.                        Philadelphia, PA 19136.
85-851   Imipramine HCl Tablets USP,  A. H. Robins Co., 1407 Cummings
          25 mg.                       Dr., P.O. Box 26609, Richmond, VA
                                       23261-6609.
86-116   Phendimetrazine Tartrate     Camall Co., P.O. Box 218,
          Tablets, 17.5 mg.            Washington, MI 48094.
86-129   Heparin Sodium Injection     Pharma-Serve, Inc., 218-20 98th
          USP, 1,000 units/ml.         Ave., Queens Village, NY 11429.
86-543   Diphenhydramine HCl          Newtron Pharmaceuticals, Inc., 155
          Capsules, 25 mg.             Knickerbocker Ave., Bohemia, NY
                                       11716.
86-544   Diphenhydramine HCl          Do.
          Capsules, 50 mg.
87-489   Hydrocortisone Lotion USP,   Heran Pharmaceutical, Inc., 7215
          1%.                          Eckhert Rd., San Antonio, TX
                                       78238.
87-628   Butalbital, Acetaminophen,   Roberts/Hauck Pharmaceuticals,
          and Caffeine Capsules, 50    Inc., Six Industrial Way West,
          mg/325 mg/40 mg.             Eatontown, NJ 07724.
87-818   Sulfacetamide Sodium         Bausch & Lomb Pharmaceuticals,
          Ophthalmic Solution, 10%.    8500 Hidden River Pkwy., Tampa,
                                       FL 33637.
87-834   Hydrocortisone USP           Torch Laboratories, Inc., P.O. Box
          (micronized powder).         248, Reisterstown, MD 21136.
87-865   Chlorpromazine HCl Tablets,  West-Ward, Inc.
          25 mg.
88-024   Phendimetrazine Tartrate     Numark Laboratories, Inc.
          Extended-Release Capsules,
          105 mg.
88-059\  Sulfacetamide Sodium and     Akorn, Inc.
 1\       Prednisolone Acetate
          Ophthalmic Suspension USP,
          10%/0.5%.
88-089   Sulfacetamide Sodium and     Bausch & Lomb Pharmaceuticals.
          Prednisolone Acetate
          Ophthalmic Suspension USP,
          10%/0.5%.
88-189   Reserpine and                West-Ward, Inc.
          Hydrochlorthiazide Tablets
          USP, 0.125 mg/50 mg.
88-255\  Theophylline Sustained-      R. P. Scherer North America, P.O.
 1\       Release Capsules, 300 mg.    Box 5600, Clearwater, FL 33518.
88-393   Hydroxyzine Pamoate          Vanguard Labs, Packaging Div. of
          Capsules, 50 mg.             MWM Corp., 101-107 Samson St.,
                                       P.O. Box K, Glasgow, KY 42141.
88-447\  Tropicamide Ophthalmic       Akorn, Inc.
 1\       Solution USP, 1%.
88-474   Triprolidine HCl and         Newtron Pharmaceuticals, Inc.
          Pseudoephedrine HCl, 1.25
          mg/5 ml and 30 mg/5 ml.
89-268   Butalbital and               Dunhall Pharmaceuticals, Inc.,
          Acetaminophen Capsules, 50   P.O. Box 100, Gravette, AR 72736.
          mg/325 mg.
89-273   Hydrocortisone Cream USP,    Topiderm, Inc., 155 Knickerbocker
          1.0%.                        Ave., Bohemia, NY 11716.
89-274   Triamcinolone Acetonide      Do.
          Cream USP, 0.025%.
89-275   Triamcinolone Acetonide      Do.
          Cream USP, 0.1%.
89-276   Triamcinolone Acetonide      Do.
          Cream USP, 0.5%.
89-495   Hydrocortisone Lotion USP,   Beta Dermaceuticals, Inc., 5419
          1%.                          Bandera Rd., suite 708, San
                                       Antonia, TX 78238.
------------------------------------------------------------------------
\1\Applicant requested withdrawal.


[[Page 8805]]

    The Director, Center for Drug Evaluation and Research, under 
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)), and under authority of 21 CFR 5.82, finds that the holders of 
the applications listed above have repeatedly failed to submit reports 
required by Sec. 314.81. Therefore, under this finding, approval of the 
applications listed above, and all amendments and supplements thereto, 
is hereby withdrawn, effective February 2, 2001.

    Dated: January 9, 2001.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 01-2790 Filed 2-1-01; 8:45 am]
BILLING CODE 4160-01-F