[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Notices]
[Page 26191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12612]


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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.

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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 Sec. 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and amendments thereto are hereby withdrawn, effective May 22, 1998.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