[Federal Register Volume 70, Number 223 (Monday, November 21, 2005)]
[Notices]
[Page 70079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of Supplemental New Animal Drug Application; 
Ivermectin and Praziquantel Paste

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 Merial, Ltd. The NADA provides for oral use of an ivermectin 
and praziquantel paste as an over-the-counter product for the treatment 
and control of various parasitic conditions of horses. This 
supplemental NADA reduces the minimum age for administration from 5 
months to 2 months of age.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
<a href="/cdn-cgi/l/email-protection#f19c949d909f9894df939483829e9fb1979590df969e87"><span class="__cf_email__" data-cfemail="dfb2bab3beb1b6baf1bdbaadacb0b19fb9bbbef1b8b0a9">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Merial, Ltd., 3239 Satellite Blvd., bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-214 for 
ZIMECTERIN GOLD (ivermectin 1.55%/praziquantel 7.75%) Paste, an over-
the-counter product used for the oral treatment and control of various 
parasitic conditions of horses. This supplemental NADA reduces the 
minimum age for administration from 5 months to 2 months of age. 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 October 28, 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(d)(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: November 7, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-22941 Filed 11-18-05; 8:45 am]
BILLING CODE 4160-01-S


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