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Notice

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

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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: melanie.berson@fda.gov.

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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 §§ 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 § 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.

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Dated: November 7, 2005.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 05-22941 Filed 11-18-05; 8:45 am]

BILLING CODE 4160-01-S