[Federal Register Volume 70, Number 243 (Tuesday, December 20, 2005)]
[Notices]
[Page 75465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of Supplemental New Animal Drug Application; 
Tilmicosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that it has approved a supplemental new animal drug application (NADA) 
filed by Elanco Animal Health. The approved NADA provides for the 
veterinary prescription use of an injectable solution of tilmicosin 
phosphate for respiratory disease in cattle and sheep. This 
supplemental NADA adds user safety information to product labeling.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 140-929 for MICOTIL 300 (tilmicosin phosphate), an 
injectable solution available by veterinary prescription for use in the 
treatment and control of respiratory disease in cattle and in the 
treatment of respiratory disease in sheep. This supplemental NADA adds 
user safety information to product labeling related to the mechanism of 
toxicity and medical intervention. In accordance with section 512(i) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(i)) 
and part 514 (21 CFR part 514) in Sec. Sec.  514.105(a) and 514.106(a), 
the Center for Veterinary Medicine is providing notice that this 
supplemental NADA is approved as of December 2, 2005. The basis of 
approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and Sec.  514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: December 8, 2005.
Bernadette Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 05-24269 Filed 12-19-05; 8:45 am]
BILLING CODE 4160-01-S