[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]
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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.
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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.
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ANDA
No. Drug Applicant
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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.
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\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