[Federal Register Volume 65, Number 60 (Tuesday, March 28, 2000)]
[Notices]
[Pages 16397-16401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1198]


John J. Ferrante et al.; Proposal to Withdraw Approval of 158 
Abbreviated New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

DATES: Submit written requests for a hearing by April 27, 2000; submit 
data and information in support of the hearing request by May 30, 2000.

ADDRESSES: 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.

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). 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.                            Drug                                       Applicant
----------------------------------------------------------------------------------------------------------------
60-058                Chloramphenicol Capsules, 250 milligrams       John J. Ferrante, c/o Operations Management
                       (mg).                                         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      Do.
                       USP.
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,      John J. Ferrante.
                       250,000, and 400,000 units.
60-173                 Tetracycline Hydrochloride (HCl) Capsules,    Do.
                       250 mg.
60-174                 Tetracycline Oral Suspension, 125 mg/5        Do.
                       milliliters (mL).
60-177                 Bacitracin-Neomycin Sulfate Polymyxin B       Do.
                       Sulfate Ointment.
60-178                 Bacitracin-Neomycin Sulfate Ointment.         Do.
60-179                 Oxytetracycline HCl Capsules, 250 mg.         Do.
60-188                 Neomycin Sulfate and Hydrocortisone           Akorn, Inc., c/o Walnut Pharmaceuticals,
                       Actetate Ophthalmic Suspension USP.           Inc., 1340 North Jefferson St., Anaheim, CA
                                                                     92807.
60-360                 Neomycin and Polymyxin B Sulfate and          Ambix Laboratories, 210 Orchard St., East
                       Bacitracin Ointment with Benzocaine.          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          Ambix Laboratories.
                       Bacitracin Ointment with Diperodon HCl.
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,           Consolidated Pharmaceutical Group, 6110
                       100,000, 200,000, 250,000, 400,000, and       Robinwood Rd., Baltimore, MD 21225.
                       500,000 units.
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     Lederle Laboratories, Division of American
                       mg.                                           Cyanamid Co., Pearl River, NY 10965.
61-676                 Ampicillin Trihydrate Capsules, 250 mg and    Public Health Service, Health Service
                       500 mg.                                       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         Holland-Rantos Co., Inc., 310 Enterprise
                       units.                                        Ave., Trenton, NJ 08638.
61-720                 Doxycycline Oral Suspension USP.              Rachelle Laboratories, Inc.

[[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/      Alpharma A.S., c/o Alpharma, Inc., One
                       vial.                                         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   Public Health Service, HAS Supply Service
                       500 mg.                                       Center.
62-359                 Bacitracin Topical Ointment, 500 units/       NMC Laboratories, Inc., 70-36 83d St.,
                       gram.                                         Glendale, NY 11385.
62-361                 Bacitracin-Neomycin-Polymyxin B Sulfate.      Do.
62-528                 Amoxicillin Capsules USP, 250 mg and 500      Laboratories Atral, S.A., c/o Louie F.
                       mg.                                           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   E-Z-EM, Inc., 717 Main St., Westbury, NY
                       USP.                                          11590.
71-320                 PEG 3350 and Electrolytes for Oral Solution   DynaPharm, Inc., P.O. Box 2141, Del Mar, CA
                       USP.                                          92014.
71-419                 Chlorhexidine Gluconate Topical Solution      Hygenics Pharmaceuticals, Inc., 26941 Cabot
                       4%.                                           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      Goldline Laboratories, 1900 West Commerical
                       Oral Solution).                               Blvd., Ft. Lauderdale, FL 33309.
72-399                Sulfamethoxazole and Trimethorprim Oral        NASKA Pharmacal Co., Inc., P.O. Box 898
                       Suspension USP.                               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/    SCS Pharmaceuticals, 4901 Searle Pkwy.,
                       100 mg, 25 mg/100 mg, and 25 mg/250 mg.       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      Akorn, Inc.
                       Solution USP.
83-400                 Propoxyphene HCl Capsules USP, 65 mg.         Rachelle Laboratories, Inc.
83-643                 Acetaminophen and Codeine Phosphate           Carnrick Laboratories, Inc., 65 Horse Hill
                       Tablets, 325 mg/30 mg.                        Rd., Cedar Knolls, NJ 07927.
83-682                 Phendimetrazine Tartrate Tablets USP, 35 mg   Zenith Laboratories, Inc., 140 Legrand
                       (yellow).                                     Ave., Northvale, NJ 07647.
83-787                 Chlorpheniramine Maleate Tablets, 4 mg.       West-Ward, Inc.

[[Page 16399]]

 
83-790                 Phendimetrazine Tartrate Tablets USP, 35      Numark Laboratories, Inc., 75 Mayfield
                       mg.                                           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              Pharmaton, Inc., c/o Bass, Ullman &
                       Epinephrine 1:50,000.                         Lustrigman, 747 Third Ave., New York, NY
                                                                     10017.
84-855                 Dexamethasone Sodium Phosphate Ophthalmic     Akorn, Inc.
                       Solution USP, 0.1%.
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        Inwood Laboratories, Inc., Subsidiary of
                       Tablets USP, 2.5 mg/0.025 mg.                 Forest Labs, Inc., 150 East 58th St., New
                                                                     York, NY 10155.
85-539                 Triamcinolone Acetonide Cream USP, 0.1%,      Zenith Goldline Pharmaceuticals, Inc.,
                       0.5%, and 0.025%.
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/    Pharma-Serve, Inc., 218-20 98th Ave.,
                       mL.                                           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,         Do.
                       0.025%.
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.

[[Page 16400]]

 
87-628                 Butalbital, Acetaminophen, and Caffeine       Roberts/Hauck Pharmaceuticals, Inc., Six
                       Capsules, 50 mg/325 mg/40 mg.                 Industrial Way West, Eatontown, NJ 07724.
87-818                 Sulfacetamide Sodium Ophthalmic Solution,     Bausch & Lomb Pharmaceuticals, 8500 Hidden
                       10%.                                          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     Numark Laboratories, Inc., 75 Mayfield
                       Capsules, 105 mg.                             Ave., Edison, NJ 08837.
88-059                 Sulfacetamide Sodium and Prednisolone         Akorn, Inc.
                       Acetate Ophthalmic Suspension USP, 10%/
                       0.5%.
88-089                 Sulfacetamide Sodium and Prednisolone         Bausch & Lomb Pharmaceuticals.
                       Acetate Ophthalmic Suspension USP, 10%/
                       0.5%.
88-189                 Reserpine and Hydrochlorthiazide Tablets      West-Ward, Inc.
                       USP, 0.125 mg/50 mg.
88-255                 Theophylline Sustained-Release Capsules,      R. P. Scherer North America, P.O. Box 5600,
                       300 mg.                                       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,     Newtron Pharmaceuticals, Inc.
                       1.25 mg/5 mL and 30 mg/5 mL.
89-268                 Butalbital and Acetaminophen Capsules, 50     Dunhall Pharmaceuticals, Inc., P.O. Box
                       mg/325 mg.                                    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   Vintage Pharmaceuticals, Inc.
                       USP, 300 mg/30 mg.
89-828                 Acetaminophen and Codeine Phosphate Tablets   Do.
                       USP, 300 mg/60 mg.
89-990                 Acetaminophen and Codeine Phosphate Tablets   Do.
                       USP, 300 mg/15 mg.
----------------------------------------------------------------------------------------------------------------

    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 
Sec. 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 Sec. 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 Sec. 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 Sec. 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,

[[Page 16401]]

Center for Drug Evaluation and Research (21 CFR 5.82).

    Dated: March 13, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-7589 Filed 3-27-00; 8:45 am]
BILLING CODE 4160-01-F