Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Notices 64385

comments and suggestions submitted

within 60 days of this publication.

Dated: November 25, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–31855 Filed 12–4–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0480]

Zenith Goldline Pharmaceuticals;

Withdrawal of Approval of 11

Abbreviated Antibiotic Applications

and 105 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 11 abbreviated antibiotic

applications (AADA’s) and 105

abbreviated new drug applications

(ANDA’s). Zenith Goldline

Pharmaceuticals notified the agency in

writing that the drug products were no

longer marketed and requested that the

approval of the applications be

withdrawn.

EFFECTIVE DATE: January 5, 1998.

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: Zenith

Goldline Pharmaceuticals, 140 Legrand

Ave., Northvale, NJ 07647, has informed

FDA that the drug products listed in the

following table are no longer marketed

and has requested that FDA withdraw

approval of the applications. Zenith

Goldline Pharmaceuticals has also, by

its request, waived its opportunity for a

hearing.

Application No. Drug

AADA 60–072 ............................................................ Penicillin G Potassium Powder, 100,000 units/5 milliliters (mL), 200,000 units/5 mL,

250,000 units/5 mL, 400,000 units/5 mL, 500,000 units/5 mL

AADA 60–073 ............................................................ Penicillin G Potassium Tablets USP, 100,000 units/Tab, 200,000 units/Tab, 250,000 units/

Tab, 400,000 units/Tab, 500,000 units/Tab

AADA 60–104 ............................................................ Chlortetracycline Hydrochloride (HCl) Capsules USP, 250 milligrams (mg)

AADA 60–518 ............................................................ Penicillin V Potassium Tablets USP, 125 mg, 250 mg, 500 mg

AADA 60–519 ............................................................ Penicillin V Potassium Powder, 125 mg/5 mL, 250 mg/5 mL

AADA 60–692 ............................................................ Ampicillin Capsules USP (Trihydrate), 250 mg, 500 mg

AADA 60–765 ............................................................ Ampicillin Capsules USP (Trihydrate), 250 mg, 500 mg

AADA 61–183 ............................................................ Ampicillin for Oral Suspension USP, 125 mg/5 mL, 250 mg/5 mL

AADA 61–468 ............................................................ Tetracycline Syrup, 125 mg/5 mL

AADA 62–237 ............................................................ Erythromycin Estolate Capsules USP, 250 mg

AADA 62–762 ............................................................ Cephradine Capsules USP, 250 mg, 500 mg

ANDA 70–360 ............................................................ Diazepam Tablets USP, 2 mg

ANDA 70–361 ............................................................ Diazepam Tablets USP, 5 mg

ANDA 70–362 ............................................................ Diazepam Tablets USP, 10 mg

ANDA 70–935 ............................................................ Perphenazine and Amitriptyline HCl Tablets USP, 2 mg/10 mg

ANDA 70–936 ............................................................ Perphenazine and Amitriptyline HCl Tablets USP, 2 mg/25 mg

ANDA 70–937 ............................................................ Perphenazine and Amitriptyline HCl Tablets USP, 4 mg/10 mg

ANDA 70–938 ............................................................ Perphenazine and Amitriptyline HCl Tablets USP, 4 mg/25 mg

ANDA 70–939 ............................................................ Perphenazine and Amitriptyline HCl Tablets USP, 4 mg/50 mg

ANDA 71–154 ............................................................ Ibuprofen Tablets USP, 200 mg (Round)

ANDA 71–458 ............................................................ Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg

ANDA 71–459 ............................................................ Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg

ANDA 71–460 ............................................................ Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/30 mg

ANDA 71–461 ............................................................ Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg

ANDA 71–552 ............................................................ Propranolol HCl and Hydrochlorothiazide Tablets USP, 40 mg/25 mg

ANDA 71–553 ............................................................ Propranolol HCl and Hydrochlorothiazide Tablets USP, 80 mg/25 mg

ANDA 72–040 ............................................................ Ibuprofen Tablets USP, 200 mg (Caplet)

ANDA 72–063 ............................................................ Propranolol HCl Tablets USP, 10 mg

ANDA 72–066 ............................................................ Propranolol HCl Tablets USP, 20 mg

ANDA 72–067 ............................................................ Propranolol HCl Tablets USP, 40 mg

ANDA 72–068 ............................................................ Propranolol HCl Tablets USP, 60 mg

ANDA 72–069 ............................................................ Propranolol HCl Tablets USP, 80 mg

ANDA 80–078 ............................................................ Nitrofurantoin Tablets (Microcrystalline) 50 mg, 100 mg

ANDA 80–143 ............................................................ Trisulfapyrimidines Tablets USP

ANDA 80–215 ............................................................ Propylthiouracil Tablets USP, 50 mg

ANDA 80–270 ............................................................ Isoniazid Tablets USP, 100 mg

ANDA 80–283 ............................................................ Prednisone Tablets USP, 5 mg

ANDA 80–378 ............................................................ Prednisolone Tablets USP, 5 mg

ANDA 80–630 ............................................................ Cortisone Acetate Tablets USP, 25 mg

ANDA 80–735 ............................................................ Dimenhydrinate Tablets USP, 50 mg

ANDA 80–762 ............................................................ Diphenhydramine HCl Capsules USP, 25 mg, 50 mg

ANDA 80–779 ............................................................ Chlorphenirarnine Maleate Tablets USP, 4 mg

ANDA 83–035 ............................................................ Vitamin A Capsules USP, 50,000 units

ANDA 83–077 ............................................................ Propoxyphene Compound Capsules
64386 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Notices

Application No. Drug

ANDA 83–180 ............................................................ Niacin Tablets USP, 500 mg

ANDA 83–190 ............................................................ Vitamin A Palmitate Capsules, 50,000 units

ANDA 83–416 ............................................................ Dexamethasone Tablets USP, 0.75 mg

ANDA 83–461 ............................................................ Pentobarbital Sodium Capsules USP, 50 mg, 100 mg

ANDA 83–484 ............................................................ Butabarbital Sodium Tablets USP, 15 mg

ANDA 83–536 ............................................................ Cortisone Acetate Tablets USP, 25 mg

ANDA 83–549 ............................................................ Chlorpromazine HCl Tablets USP, 10 mg, 25 mg, 50 mg

ANDA 83–568 ............................................................ Reserpine and Hydrochlorothiazide Tablets USP, 0.1 mg/50 mg

ANDA 83–570 ............................................................ Chlordiazepoxide HCl Capsules USP, 25 mg

ANDA 83–571 ............................................................ Reserpine and Hydrochlorothiazide Tablets USP, 0.125 mg/25 mg

ANDA 83–572 ............................................................ Reserpine and Hydrochlorothiazide Tablets USP, 0.1 mg/25 mg

ANDA 83–573 ............................................................ Reserpine and Hydrochlorothiazide Tablets USP, 0.125 mg/50 mg

ANDA 83–574 ............................................................ Chlorpromazine HCl Tablets USP, 100 mg

ANDA 83–575 ............................................................ Chlorpromazine HCl Tablets USP, 200 mg

ANDA 83–597 ............................................................ Propoxyphene HCl Capsules USP, 32 mg

ANDA 83–603 ............................................................ Promethazine HCl Tablets USP, 25 mg

ANDA 83–604 ............................................................ Promethazine HCl Tablets USP, 12.5 mg

ANDA 83–610 ............................................................ Isoniazid Tablets USP, 300 mg

ANDA 83–613 ............................................................ Promethazine HCl Tablets USP, 50 mg

ANDA 83–741 ............................................................ Chlordiazepoxide HCl Capsules USP, 5 mg

ANDA 83–742 ............................................................ Chlordiazepoxide HCl Capsules USP, 10 mg

ANDA 83–750 ............................................................ Triamcinolone Tablets USP, 4 mg

ANDA 83–784 ............................................................ Meclizine HCl Tablets USP, 12.5 mg

ANDA 83–876 ............................................................ Hydralazine HCl and Hydrochlorothiazide Tablets, 25 mg/15 mg

ANDA 83–877 ............................................................ Reserpine, Hydralazine HCl, and Hydrochlorothiazide Tablets USP, 0.1 mg/25 mg/15 mg

ANDA 84–040 ............................................................ Butabarbital Sodium Tablets USP, 30 mg

ANDA 84–133 ............................................................ Prednisone Tablets USP, 10 mg

ANDA 84–134 ............................................................ Prednisone Tablets USP, 20 mg

ANDA 84–181 ............................................................ Meprobamate Tablets USP, 600 mg

ANDA 84–291 ............................................................ Reserpine, Hydralazine HCl and Hydrochlorothiazide Tablets USP, 0.1 mg/25 mg/15 mg

ANDA 84–351 ............................................................ Brompheniramine Maleate Tablets USP, 4 mg

ANDA 84–437 ............................................................ Hydralazine HCl Tablets USP, 25 mg

ANDA 84–443 ............................................................ Hydralazine HCl Tablets USP, 10 mg

ANDA 84–469 ............................................................ Hydralazine HCl Tablets USP, 50 mg

ANDA 84–473 ............................................................ Isosorbide Dinitrate Sublingual Tablets USP, 2.5 mg

ANDA 84–474 ............................................................ Isosorbide Dinitrate Sublingual Tablets USP, 5 mg

ANDA 84–549 ............................................................ Quinidine Sulfate Tablets USP, 200 mg

ANDA 84–581 ............................................................ Hydralazine HCl Tablets USP, 100 mg

ANDA 84–648 ............................................................ Methocarbamol Tablets USP, 500 mg

ANDA 84–649 ............................................................ Methocarbamol Tablets USP, 750 mg

ANDA 84–658 ............................................................ Hydrochlorothiazide Tablets USP, 50 mg

ANDA 84–689 ............................................................ Bethanechol Chloride Tablets USP, 25 mg

ANDA 84–976 ............................................................ Meclizine HCl Tablets USP, 25 mg

ANDA 85–273 ............................................................ Triprolidine and Pseudoephedrine Hydrochlorides Tablets USP, 2.5 mg/60 mg

ANDA 85–441 ............................................................ Butalbital Compound Tablets USP, 50 mg/325 mg

ANDA 85–553 ............................................................ Phenterimine HCl Tablets, 8 mg

ANDA 85–611 ............................................................ Phendimetrazine Tartrate Tablets USP, 35 mg

ANDA 85–612 ............................................................ Phendimetrazine Tartrate Tablets USP, 35 mg

ANDA 85–682 ............................................................ Phendimetrazine Tartrate Tablets USP, 35 mg

ANDA 85–869 ............................................................ Secobarbital Sodium Capsules USP, 100 mg

ANDA 86–035 ............................................................ Isosorbide Dinitrate Tablets USP, 10 mg

ANDA 86–329 ............................................................ Phentermine HCl Capsules USP, 30 mg

ANDA 87–004 ............................................................ Spironolactone and Hydrochlorothiazide Tablets USP, 25 mg/25 mg

ANDA 87–008 ............................................................ Dipyridamole Tablets USP, 25 mg

ANDA 87–108 ............................................................ Spironolactone Tablets USP, 25 mg

ANDA 87–186 ............................................................ Ergoloid Mesylates Tablets USP (Sublingual), 0.5 mg

ANDA 87–216 ............................................................ Hydroxyzine HCl Tablets USP, 10 mg

ANDA 87–316 ............................................................ Dipyridamole Tablets USP, 50 mg

ANDA 87–320 ............................................................ Dipyridamole Tablets USP, 75 mg

ANDA 87–353 ............................................................ Chlorpropamide Tablets USP, 250 mg

ANDA 87–410 ............................................................ Hydroxyzine HCl Tablets USP, 25 mg

ANDA 87–411 ............................................................ Hydroxyzine HCl Tablets USP, 50 mg

ANDA 87–555 ............................................................ Chlorthalidone Tablets USP, 25 mg

ANDA 87–769 ............................................................ Sulfinpyrazone Tablets USP, 100 mg

ANDA 87–786 ............................................................ Methyclothiazine Tablets USP, 5 mg

ANDA 87–947 ............................................................ Chlorthalidone Tablets USP, 50 mg

ANDA 88–218 ............................................................ Phenylbutazone Capsules USP, 100 mg

ANDA 88–356 ............................................................ Hydralazine HCl and Hydrochlorothiazide Capsules, 25 mg/25 mg

ANDA 88–357 ............................................................ Hydralazine HCl and Hydrochlorothiazide Capsules, 50 mg/50 mg

ANDA 88–358 ............................................................ Hydralazine HCl and Hydrochlorothiazide Capsules, 100 mg/50 mg

ANDA 88–840 ............................................................ Chlorpropamide Tablets USP, 100 mg
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Notices 64387

Application No. Drug

ANDA 88–932 ............................................................ Reserpine and Hydroflumethiazide Tablets, 0.125 mg/50 mg

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

in the table in this document, and all

amendments and supplements thereto,

is hereby withdrawn, effective January

5, 1998.

Dated: November 17, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–31879 Filed 12–4–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Oncologic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 18, 1997, 8:30 a.m. to

5:05 p.m., and December 19, 1997, 8

a.m. to 4:35 p.m.

Location: Holiday Inn, Versailles

Ballrooms I, II, and III, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Jannette O’NeillGonzalez, or Robinette Taylor, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12542.

Please call the Information Line for upto-date information on this meeting.

Agenda: On December 18, 1997, the

committee will discuss: (1) New drug

application (NDA) supplement 16–295/

S–029, Droxia (hydroxyurea capsules,

USP), for the treatment of sickle cell

anemia in adult patients to prevent

painful crises and to reduce the need for

blood transfusions; and (2) NDA 20–

798, Depocyt (cytarabine lipid-particle

injection), for the intrathecal treatment

of neoplastic meningitis of patients with

solid tumors, lymphoma, or leukemia.

On December 19, 1997, the committee

will discuss: (1) Biologics licensing

application (BLA) supplement 97–0501,

Proleukin/Aldesleukin (recombinant

human interlukin-2), for the treatment

of adult patients with metastatic

melanoma; and (2) NDA 20–806,

Neomark (broxuridine for injection),

for use as a cell proliferation marker to

determine the labeling index in breast

cancer.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by December 10, 1997. Oral

presentations from the public will be

scheduled between approximately 8:35

a.m. and 9:05 a.m. on December 18,

1997, and between approximately 8:05

a.m. and 8:35 a.m. on December 19,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 10, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

December 18, 1997, Oncologic Drugs

Advisory Committee meeting. Because

the agency believes there is some

urgency to bring these issues to public

discussion and qualified members of the

Oncologic Drugs Advisory Committee

were available at this time, the

Commissioner concluded that it was in

the public interest to hold this meeting

even if there was not sufficient time for

the customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 26, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–31808 Filed 12–4–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0442]

Memoranda of Understanding Between

the Food and Drug Administration and

the United States Department of

Agriculture

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) and the United

States Department of Agriculture

(USDA) have revised three memoranda

of understanding (MOU’s) with regard

to control of aflatoxin in peanuts, inshell Brazil nuts, and in-shell pistachio

nuts. The purpose of the MOU’s is to set

forth the responsibility for aflatoxin

testing of domestic and imported raw

peanuts, imported in-shell Brazil nuts,

and imported in-shell pistachio nuts.

DATES: The MOU’s became effective

October 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Henry Kim, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–260–0631.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and MOU’s signed by FDA and other

departments, agencies, and

organizations shall be published in the

Federal Register, the agency is

publishing three revised MOU’s

between FDA and USDA that set forth

the responsibility for aflatoxin testing of

domestic and imported raw peanuts,

imported in-shell Brazil nuts, and

imported in-shell pistachio nuts.

Dated: November 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

The text of the three MOU’s follows:

Agreement No.