Source: https://www.federalregister.gov/documents/2000/03/28/00-7589/john-j-ferrante-et-al-proposal-to-withdraw-approval-of-158-abbreviated-new-drug-applications
Timestamp: 2017-09-21 19:55:13
Document Index: 446952367

Matched Legal Cases: ['§\u2009314', '§\u2009314', 'art 314', '§\u2009314', 'art 12', '§\u2009314', '§\u2009314']

Federal Register :: John J. Ferrante et al.; Proposal to Withdraw Approval of 158 Abbreviated New Drug Applications; Opportunity for a Hearing
John J. Ferrante et al.; Proposal to Withdraw Approval of 158 Abbreviated New Drug Applications; Opportunity for a Hearing
A Notice by the Food and Drug Administration on 03/28/2000
Submit written requests for a hearing by April 27, 2000; submit data and information in support of the hearing request by May 30, 2000.
65 FR 16397
16397-16401 (5 pages)
Docket No. 00N-1198
00-7589
https://www.federalregister.gov/d/00-7589 https://www.federalregister.gov/d/00-7589
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 158 abbreviated new drug applications (ANDA's). The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.
Requests for a hearing, supporting data, and other comments are to be identified with Docket No. 00N-1198 and submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Olivia A. Pritzlaff, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
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). The holders of the applications listed in the following table have failed to submit the required annual reports and have not responded to the agency's request by certified mail for submission of the reports.
ANDA No.
60-058 Chloramphenicol Capsules, 250 milligrams (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 Hydrochloride (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 Neomycin Sulfate and Hydrocortisone Actetate 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 Ointment 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.
60-453 Neomycin and Polymyxin B Sulfate and Bacitracin Ointment with Diperodon HCl. Ambix Laboratories.
60-464 Neomycin Sulfate and Prednisolone. The Upjohn Co.
60-647 Neo-Polycin Opthalmic 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 Tetracycline HCl Susceptibility Power, 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 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.
Start Printed Page 16398
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 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 Bacitracin USP, 50,000 and 10,000 units/vial. Alpharma A.S., c/o Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024.
62-042 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.
62-538 Doxycycline Hyclate Tablets USP, 100 mg. Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd., Charlotte, NC 28206.
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.
71-419 Chlorhexidine Gluconate Topical Solution 4%. Hygenics Pharmaceuticals, Inc., 26941 Cabot Rd., suite 128, Laguna Hills, CA 92653.
71-639 Ibuprofen Tablets USP, 200 mg. Vintage Pharmaceuticals, Inc.
71-644 Ibuprofen Tablets USP, 400 mg. Do.
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, and 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.
81-008 Chlorzoxazone Tablets USP, 500 mg. Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, MI 48220.
83-102 Vitamin D Capsules, 50,000 units. West-Ward, Inc.
83-156 Hydrocortisone Acetate Cream, 1.0%. Parke-Davis, Div. of Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950.
83-161 Dexamethasone Sodium Phosphate Injection. Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666.
83-358 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.
83-682 Phendimetrazine Tartrate Tablets USP, 35 mg (yellow). Zenith Laboratories, Inc., 140 Legrand Ave., Northvale, NJ 07647.
83-787 Chlorpheniramine Maleate Tablets, 4 mg. West-Ward, Inc.
Start Printed Page 16399
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.
84-185 Bethanechol Chloride Tablets, 10 mg. Wendt Laboratories, Inc., 100 Nancy Dr., P.O. Box 128, Belle Plaine, MN 56011.
84-186 Bethanechol Chloride Tablets, 25 mg. Do.
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 Prednisone Capsules, 50 mg. R. P. Scherer Corp., 2725 Scherer Dr., St. Petersburg, FL 33702.
84-492 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 Dexamethasone Sodium Phosphate Ophthalmic Solution USP, 0.1%. Akorn, Inc.
85-039 Folic Acid Tablets USP, 1 mg. Wendt Laboratories, Inc.
85-040 Isoniazed Tablets USP, 100 mg. Do.
85-041 Meclizine HCl Tablets, 25 mg. Do.
85-042 Methocarbamol Tablets USP, 500 mg. Do.
85-044 Reserpine Tablets USP, 0.25 mg. Do.
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.
85-539 Triamcinolone Acetonide Cream USP, 0.1%, 0.5%, and 0.025%. Zenith Goldline Pharmaceuticals, Inc.,
85-630 Trichlormethiazide Tablets, 4 mg. Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136.
85-733 Hydrocortisone Cream USP, 1%. Zenith Goldine Pharmaceuticals, Inc.
85-777 Selenium Sulfide USP. Do.
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.
86-766 Nitrofurazone Ointment 0.2%. Wendt Laboratories, Inc.
87-081 Nitrofurazone Solution 0.2%. Do.
87-328 Trifluoperazine HCl Tablets USP, 5 mg. Zenith Goldline Pharmaceuticals, Inc.
87-375 Triamcinolone Acetonide Ointment USP, 0.025%. Do.
87-376 Triamcinolone Acetonide Ointment USP, 0.5%. Do.
87-377 Triamcinolone Acetonide Ointment USP, 0.1%. Do.
87-427 Hydrocortisone Cream USP, 1%. Do.
87-428 Triamcinolone Acetonide Cream USP, 0.5%. Do.
87-429 Triamcinolone Acetonide Cream USP, 0.1%. Do.
87-430 Triamcinolone Acetonide Cream USP, 0.025%. Do.
87-489 Hydrocortisone Lotion USP, 1%. Heran Pharmaceutical, Inc., 7215 Eckhert Rd., San Antonio, TX 78238.
87-612 Trifluoperazine HCl Tablets USP, 1 mg. Zenith Goldline Pharmaceuticals, Inc.
87-613 Trifluoperazine HCl Tablets USP, 2 mg. Do.
87-614 Trifluoperazine HCl Tablets USP, 10 mg. Do.
Start Printed Page 16400
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., 75 Mayfield Ave., Edison, NJ 08837.
88-059 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 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 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 Antonio, TX 78238.
89-805 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg. Vintage Pharmaceuticals, Inc.
89-828 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg. Do.
89-990 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg. Do.
Therefore, notice is given to the holders of the applications listed in the table and to all other interested persons that the Director of the Center for Drug Evaluation and Research proposes to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) withdrawing approval of the applications and all amendments and supplements thereto on the ground that the applicants have failed to submit reports required under § 314.81.
In accordance with section 505 of the act and 21 CFR part 314, the applicants are hereby provided an opportunity for a hearing to show why the applications listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these applications.
An applicant who decides to seek a hearing shall file: (1) On or before April 27, 2000, a written notice of participation and request for a hearing, and (2) on or before May 30, 2000, the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing. Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation and request for a hearing, information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 and in 21 CFR part 12.
The failure of an applicant to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that applicant not to avail itself of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the applications and the drug products may not thereafter lawfully be marketed, and FDA will begin appropriate regulatory action to remove the products from the market. Any new drug product marketed without an approved new drug application is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. Reports submitted to remedy the deficiencies must be complete in all respects in accordance with § 314.81. If the submission is not complete or if a request for a hearing is not made in the required format or with the required reports, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing.
All submissions under this notice of opportunity for a hearing must be filed in four copies. Except for data and information prohibited from public disclosure under section 301 of the act (21 U.S.C. 331(j)) or 18 U.S.C. 1905, the submissions may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic Act (sec. 505 (21 U.S.C. 355)) and under authority delegated to the Director, Start Printed Page 16401Center for Drug Evaluation and Research (21 CFR 5.82).
[FR Doc. 00-7589 Filed 3-27-00; 8:45 am]