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

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 § 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

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, 250 mg.

John J. Ferrante, c/o Operations 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 Procaine Suspension USP.

Do.

60-110

Sterile Dihydrostreptomycin Sulfate USP.

Pfizer Central Research, Pfizer, Inc., Eastern Point Rd., Groton, CT 06340.

60-170

Penicillin G Potassium Tablets, 200,000, 250,000, and 400,000 units.

John J. Ferrante.

60-173

Tetracycline HCl Capsules, 250 mg.

Do.

60-174

Tetracycline Oral Suspension, 125 mg/5 milliliters (ml).

Do.

60-177

Bacitracin-Neomycin Sulfate Polymyxin B Sulfate Ointment.

Do.

60-178

Bacitracin-Neomycin Sulfate Ointment.

Do.

60-179

Oxytetracycline HCl Capsules, 250 mg.

Do.

60-188

1

Neomycin Sulfate and Hydrocortisone Acetate Ophthalmic Suspension USP.

Akorn, Inc., c/o Walnut Pharmaceuticals, Inc., 1340 North Jefferson St., Anaheim, CA 92807.

60-360

Neomycin and Polymyxin B Sulfate and Bacitracin with Benzocaine.

Ambix Laboratories, 210 Orchard St., East Rutherford, NJ 07073.

60-435

Tetracycline HCl Tablets USP, 250 mg.

Farmitalia Carlo Erba S.p.A., c/o Montedison, USA, Inc., 1114 Avenue of the Americas, New York, NY 10036.

60-464

Neomycin Sulfate and Prednisolone.

The Upjohn Co.

60-647

Neo-Polycin Ophthalmic Ointment.

Merrell Dow Pharmaceuticals, Inc., P.O. Box 68511, Indianapolis, IN 46268.

60-666

Ampicillin Tihydrate for Oral Suspension.

Beecham Laboratories, 501 Fifth St., Bristol, TN 37620.

60-690

Oxytetracycline HCl.

Pierrel America, Inc., 576 Fifth Ave., New York, NY 10036.

60-720

Tetracycline HCl Capsules, 250 mg.

Towne Paulsen & Co., Inc., 140 East Duarte Rd., Monrovia, CA 91016.

60-757

Polymyxin B Sulfate, 500,000 units.

Burroughs Wellcome Co., 3030 Cornwallis Rd., Research Triangle Park, NC 27709.

60-774

Griseofulvin Tablets, 500 mg.

McNeil Consumer, Inc., Camp Hill Rd., Fort Washington, PA 19034.

60-809

Penicillin G Potassium Tablets USP, 100,000, 200,000, 250,000, 400,000, and 500,000 units.

Consolidated Pharmaceutical Group, 6110 Robinwood Rd., Baltimore, MD 21225.

60-855

Oxytetracycline HCl Capsules, 250 mg.

Rachelle Laboratories, Inc., 700 Henry Ford Ave., P.O. Box 2029, Long Beach, CA 90801.

60-869

Oxytetracycline HCl Capsule, 250 mg.

Proter S.p.A., c/o Arnold Buhl Christen, 1000 Connecticut Ave., Washington, DC 20086.

61-174

Candicidin.

Penick Corp., 1050 Wall St. West, Lyndhurst, NJ 07071.

61-396

Hetacillin Capsules.

Bristol-Myers, U.S. Pharmaceutical Group, Evansville, IN 47721- 0001.

61-523

1

Tetracycline HCl Susceptibility Powder, 20 mg.

Lederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965.

61-676

Ampicillin Trihydrate Capsules, 250 mg and 500 mg.

Public Health Service, Health Service Administration, Perry Point, MD 21902.

61-700

1

Bacitracin Zinc USP for Compounding.

Alpharma A. S., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024.

61-718

Nystatin Vaginal Tablets USP, 100,000 units.

Holland-Rantos Co., Inc., 310 Enterprise Ave., Trenton, NJ 08638.

61-720

Doxycycline Oral Suspension USP.

Rachelle Laboratories, Inc.

61-933

Penicillin G Potassium for Injection USP.

E. R. Squibb & Sons, P.O. Box 191, New Brunswick, NJ 08903-0191.

61-953

Doxycycline Hyclate Injection.

Rachelle Laboratories, Inc., P.O. Box 187, Culver, IN 46511.

61-957

Benzylpenicilloyl Polylysine Injection.

Kremers-Urban Co., 5600 West County Line Rd., P.O. Box 2038, Milwaukee, WI 53201.

61-961

1

Bacitracin Ointment USP.

Clay-Park Labs, Inc., 1700 Bathgate Ave., Bronx, NY 10457.

61-994

Kanamycin Sulfate Injection USP.

Bristol Laboratories, Division of Bristol-Myers Co., P.O. Box 657, Syracuse, NY 13201.

62-007

1

Bacitracin USP, 50,000 and 10,000 units/vial.

Alpharma A. S.

62-042

1

Chloramphenicol Ophthalmic Solution, 0.5%.

Akorn, Inc.

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 Injection USP.

The Upjohn Co.

62-345

Tetracycline HCl Capsules, 250 mg.

Public Health Service, HAS Supply Service Center, Perry Point, MD 21902.

62-354

Gentamicin Sulfate Injection USP.

Kalapharm, Inc., 145 East 27th St., New York, NY 10016.

62-357

Amoxicillin Trihydrate Capsules, 250 mg and 500 mg.

Public Health Service, HAS Supply Service Center.

62-359

Bacitracin Topical Ointment, 500 units/gram.

NMC Laboratories, Inc., 70-36 83d St., Glendale, NY 11385.

62-361

Bacitracin-Neomycin-Polymyxin B Sulfate.

Do.

62-528

Amoxicillin Capsules USP, 250 mg and 500 mg.

Laboratories Atral, S.A., c/o Louie F. Turner, P.O. Box 331044, Fort Worth, TX 76133-2924.

71-278

PEG 3350 and Electrolytes for Oral Solution USP.

E-Z-EM, Inc., 717 Main St., Westbury, NY 11590.

71-320

PEG 3350 and Electrolytes for Oral Solution USP.

DynaPharm, Inc., P.O. Box 2141, Del Mar, CA 92014.

71-777

Clorazepate Dipotassium Capsules, 3.75 mg.

Able Laboratories, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.

71-778

Clorazepate Dipotassium Capsules, 7.5 mg.

Do.

71-779

Clorazepate Dipotassium Capsules, 15 mg.

Do.

72-319

Glycoprep (PEG 3350 and Electrolytes for Oral Solution).

Goldline Laboratories, 1900 West Commerical Blvd., Ft. Lauderdale, FL 33309.

72-399

Sulfamethoxazole and Trimethorprim Oral Suspension USP.

NASKA Pharmacal Co., Inc., P.O. Box 898 Riverview Rd., Lincolnton, NC 28093.

72-409

Nifedipine Capsules USP, 10 mg.

Chase Laboratories, Inc., 280 Chestnut St., Newark, NJ 07105.

73-421

Nifedipine Capsules USP, 20 mg.

Do.

74-080

Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, 25 mg/250 mg.

SCS Pharmaceuticals, 4901 Searle Pkwy., Skokie, IL 60077.

80-094

Triple Sulfoid Tablets.

Pal-Pak, Inc., 1201 Liberty St., Allentown, PA 18102.

80-117

Nitrofurantoin Tablets, 50 mg.

Rachelle Laboratories, Inc., 700 Henry Ford Ave., P.O. Box 2029, Long Beach, CA 90801.

80-118

Nitrofurantoin Tablets, 100 mg.

Do.

80-335

Prednisolone Tablets, 5 mg.

Central Pharmaceutical, Inc., 110-128 East Third St., Seymour, IN 47274.

80-375

Lidocaine HCl Injection USP, 2%.

Rachelle Laboratories, Inc.

80-376

Lidocaine HCl Injection USP, 1%.

Do.

80-481

Hydrocortisone Ointment USP.

C & M Pharmacal, Inc., 1721 Maple Lane, Hazel Park, MI 48030-1215.

80-482

Hydrocortisone Cream USP.

Do.

80-562

Prednisolone Tablets, 2.5 mg and 5 mg.

John J. Ferrante.

80-568

Hydrocortisone Tablets, 10 mg and 20 mg.

Do.

80-967

Vitamin A Capsules USP.

West-Ward, Inc., 465 Industrial Lane, Eatontown, NJ 07724.

83-102

Vitamin D Capsules, 50,000 units.

Do.

83-156

Hydrocortisone Acetate Cream, 1.0%.

Parke-Davis, Div. of Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950.

83-161

1

Dexamethasone Sodium Phosphate Injection.

Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666.

83-358

1

Prednisolone Sodium Phosphate Ophthalmic Solution USP.

Akorn, Inc.

83-400

Propoxyphene HCl Capsules USP, 65 mg.

Rachelle Laboratories, Inc.

83-643

Acetaminophen and Codeine Phosphate Tablets, 325 mg/30 mg.

Carnrick Laboratories, Inc., 65 Horse Hill Rd., Cedar Knolls, NJ 07927.

83-787

Chlorpheniramine Maleate Tablets, 4 mg.

West-Ward, Inc.

83-790

Phendimetrazine Tartrate Tablets USP, 35 mg.

Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837.

83-791

Nitrofurazone Powder.

Roberts Laboratories, Inc., 4 Industrial Way West, Eatontown, NJ 07724.

83-829

Chlorpromazine HCl Tablets USP.

Rachelle Laboratories, Inc.

83-977

Selenium Sulfide.

USV Pharmaceutical Corp., One Scarsdale Rd., Tuckahoe, NY 10707.

84-030

Meprobamate Tablets, 400 mg.

Ferndale Laboratories, Inc.

84-255

Sulfasalazine Tablets, 500 mg.

William H. Rorer, Inc., 500 Virginia Dr., Fort Washington, PA 19034.

84-337

Sulfisoxasole Tablets, 500 mg.

Rachelle Laboratories, Inc.

84-377

1

Prednisone Capsules, 50 mg.

R. P. Scherer Corp., 2725 Scherer Dr., St. Petersburg, FL 33702.

84-492

1

Prednisolone Acetate Injection.

Akorn, Inc.

84-563

Aminophylline Tablets, 200 mg.

ICN Pharmaceuticals, Inc., 5040 Lester Rd., Cincinnati, OH 45213.

84-639

Chlordiazepoxide HCl Capsules USP, 10 mg.

Rachelle Laboratories, Inc.

84-727

Lidocaine HCl Injection, 2%.

Pharmaton, Inc., 150 East 58th St., New York, NY 19155.

84-728

Lidocaine HCl Injection, 2% with Epinephrine 1:50,000.

Pharmaton, Inc., c/o Bass, Ullman & Lustrigman, 747 Third Ave., New York, NY 10017.

84-855

1

Dexamethasone Sodium Phosphate Ophthalmic Solution USP, 0.1%.

Akorn, Inc.

85-086

Chlordiazepoxide HCl Capsules, 5 mg.

Rachelle Laboratories, Inc.

85-087

Chlordiazepoxide HCl Capsules USP, 25 mg.

Do.

85-091

Isoniazid Tablets USP, 100 mg.

Pharmavite Corp., 15451 San Fernando Mission Blvd., P.O. Box 9606, Mission Hills, CA 91346-9606.

85-104

Chlorpheniramine Maleate Tablets USP, 4 mg.

Do.

85-118

Chlordiazepoxide HCl Capsules, 5 mg.

John J. Ferrante.

85-119

Chlordiazepoxide HCl Capsules, 10 mg.

Do.

85-120

Chlordiazepoxide HCl Capsules, 25 mg.

Do.

85-341

Butabartital Sodium Tablets USP, 30 mg.

Vale Chemical Co., Inc., 1201 Liberty St., Allentown, PA 18102.

85-345

Butabartital Sodium Tablets USP, 15 mg.

Do.

85-477

Secobarbital Sodium Capsules, 100 mg.

ICN Pharmaceuticals, Inc., 222 North Vincent Ave., Covina, CA 91722.

85-509

Diphenoxylate HCl and Atropine Sulfate Tablets USP, 2.5 mg/0.025 mg.

Inwood Laboratories, Inc., Subsidiary of Forest Labs, Inc., 150 East 58th St., New York, NY 10155.

85-630

Trichlormethiazide Tablets, 4 mg.

Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136.

85-851

Imipramine HCl Tablets USP, 25 mg.

A. H. Robins Co., 1407 Cummings Dr., P.O. Box 26609, Richmond, VA 23261-6609.

86-116

Phendimetrazine Tartrate Tablets, 17.5 mg.

Camall Co., P.O. Box 218, Washington, MI 48094.

86-129

Heparin Sodium Injection USP, 1,000 units/ml.

Pharma-Serve, Inc., 218-20 98th Ave., Queens Village, NY 11429.

86-543

Diphenhydramine HCl Capsules, 25 mg.

Newtron Pharmaceuticals, Inc., 155 Knickerbocker Ave., Bohemia, NY 11716.

86-544

Diphenhydramine HCl Capsules, 50 mg.

Do.

87-489

Hydrocortisone Lotion USP, 1%.

Heran Pharmaceutical, Inc., 7215 Eckhert Rd., San Antonio, TX 78238.

87-628

Butalbital, Acetaminophen, and Caffeine Capsules, 50 mg/325 mg/40 mg.

Roberts/Hauck Pharmaceuticals, Inc., Six Industrial Way West, Eatontown, NJ 07724.

87-818

Sulfacetamide Sodium Ophthalmic Solution, 10%.

Bausch & Lomb Pharmaceuticals, 8500 Hidden River Pkwy., Tampa, FL 33637.

87-834

Hydrocortisone USP (micronized powder).

Torch Laboratories, Inc., P.O. Box 248, Reisterstown, MD 21136.

87-865

Chlorpromazine HCl Tablets, 25 mg.

West-Ward, Inc.

88-024

Phendimetrazine Tartrate Extended-Release Capsules, 105 mg.

Numark Laboratories, Inc.

88-059

1

Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Suspension USP, 10%/0.5%.

Akorn, Inc.

88-089

Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Suspension USP, 10%/0.5%.

Bausch & Lomb Pharmaceuticals.

88-189

Reserpine and Hydrochlorthiazide Tablets USP, 0.125 mg/50 mg.

West-Ward, Inc.

88-255

1

Theophylline Sustained-Release Capsules, 300 mg.

R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518.

88-393

Hydroxyzine Pamoate Capsules, 50 mg.

Vanguard Labs, Packaging Div. of MWM Corp., 101-107 Samson St., P.O. Box K, Glasgow, KY 42141.

88-447

1

Tropicamide Ophthalmic Solution USP, 1%.

Akorn, Inc.

88-474

Triprolidine HCl and Pseudoephedrine HCl, 1.25 mg/5 ml and 30 mg/5 ml.

Newtron Pharmaceuticals, Inc.

89-268

Butalbital and Acetaminophen Capsules, 50 mg/325 mg.

Dunhall Pharmaceuticals, Inc., P.O. Box 100, Gravette, AR 72736.

89-273

Hydrocortisone Cream USP, 1.0%.

Topiderm, Inc., 155 Knickerbocker Ave., Bohemia, NY 11716.

89-274

Triamcinolone Acetonide Cream USP, 0.025%.

Do.

89-275

Triamcinolone Acetonide Cream USP, 0.1%.

Do.

89-276

Triamcinolone Acetonide Cream USP, 0.5%.

Do.

89-495

Hydrocortisone Lotion USP, 1%.

Beta Dermaceuticals, Inc., 5419 Bandera Rd., suite 708, San Antonia, TX 78238.

1

Applicant requested withdrawal.

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 § 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]

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