97-18456. Elanco Animal Health; Withdrawal of Approval of NADA

[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Notices]
[Pages 37924-37925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0226]


Elanco Animal Health; Withdrawal of Approval of NADA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) held by Elanco Animal Health. 
The NADA provides for the use of tylosin soluble powder in animal 
drinking water. The sponsor requested the withdrawal of approval of the 
NADA because the animal drug product is no longer being marketed.

EFFECTIVE DATE: July 25, 1997.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, is the 
sponsor of NADA 13-029 Tylan Plus Vitamins (tylosin), which 
provides for the use of tylosin in swine drinking water for control and 
treatment of swine dysentery. Elanco Animal Health requested withdrawal 
of approval of the NADA because the animal drug product is no longer 
being 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 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA 13-029 and all supplements and amendments thereto is 
hereby withdrawn, effective July 25, 1997.

[[Page 37925]]

    Dated: June 20, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-18456 Filed 7-14-97; 8:45 am]
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