Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Notices 26191

CONTACT PERSON FOR MORE INFORMATION:

Joseph R. Coyne, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.bog.frb.fed.us for an electronic

announcement that not only lists

applications, but also indicates

procedural and other information about

the meeting.

Dated: May 8, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–12656 Filed 5–8–98; 12:29 pm]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Pfizer, Inc.; Withdrawal of Approval of

NADA’s

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of four new animal drug

applications (NADA’s) held by Pfizer,

Inc. The NADA’s provide for use of

oxytetracycline hydrochloride. The

sponsor requested the withdrawal of

approval of the NADA’s because the

animal drug products are no longer

manufactured or marketed.

EFFECTIVE DATE: May 12, 1998.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0212.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017 is the sponsor of NADA 8–696

TM–5 Antibiotic Feed Supplement

(oxytetracycline), NADA 10–661

Terramycin Egg Formula

(oxytetracycline hydrochloride), NADA

11–034 Liquimast Solution for Mastitis

(oxytetracycline hydrochloride), and

NADA 13–470 TM–10 Premix

(oxytetracycline). The animal drug

products were subject to review under

the National Academy of Sciences/

National Research Council, Drug

Efficacy Study Implementation Program,

and are currently subject to

requirements for finalization under that

program. Pfizer, Inc., the current

sponsor, requested withdrawal of

approval of the NADA’s because the

animal drug products are no longer

manufactured or marketed.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.48), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approvals of NADA’s 8–696, 10–661,

11–034, 13–470, and all supplements

and amendments thereto are hereby

withdrawn, effective May 22, 1998. These products had not been the

subject of a regulation published under

section 512 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360b).

Therefore, an amendment to the animal

drug regulations to reflect the

withdrawal of approvals is not required.

Dated: April 24, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–12612 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0285]

Sanofi Pharmaceuticals, Inc., et al.;

Withdrawal of Approval of 21 New

Drug Applications and 62 Abbreviated

New Drug Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 21 new drug applications

(NDA’s) and 62 abbreviated new drug

applications (ANDA’s). The holders of

the applications 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: June 11, 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: The

holders of the applications listed in the

table in this document have informed

FDA that these drug products are no

longer marketed and have requested that

FDA withdraw approval of the

applications. The applicants have also,

by their request, waived their

opportunity for a hearing.

Application No. Drug Applicant

NDA 4–496 Pipanol Powder and Tablets (trihyphenidyl) Sanofi Pharmaceuticals, Inc., 90 Park Ave., New York,

NY 10016.

NDA 6–328 Isuprel (isoproterenol hydrochloride) Sublingual Tablets, 10 milligrams (mg) and 15 mgDo.

NDA 7–514 Insulin, NPH Iletin Eli Lilly and Co., Lilly Corporate Center, Indianapolis,

IN 46285.

NDA 8–256 Insulin Do.

NDA 8–717 Acetaminophen Tablets USP (acetaminophen tablets) Roxane Laboratories, Inc., P.O. Box 16532, Columbus,

OH 43216–6532.

NDA 8–847 Sucostrin (succinylcholine chloride injection) Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543–

4500.

NDA 8–983 Arfonad (trimethaphan camsylate) Ampules Hoffmann-La Roche, Inc., 40 Kingsland St., Nutley, NJ

07110–1199.

NDA 9–088 Neothylline (dyphylline) injection TEVA Pharmaceuticals USA (formerly Lemmon Co.),

650 Cathill Rd., Sellersvile, PA 18960.

NDA 9–300 Insulin, Lente Iletin I Eli Lilly and Co.

NDA 9–410 Lotusate Tablets and and Capsules (talbutal) Sanofi Pharmaceuticals, Inc.

NDA 9–479 Jayne’s Liquid Vermifuge (piperazine hexahydrate) Do.