[Federal Register Volume 69, Number 171 (Friday, September 3, 2004)]
[Notices]
[Page 53925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20178]


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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 Virbac AH, Inc. The supplemental NADA provides for use of an 
ivermectin and praziquantel oral paste for the treatment and control of 
various species of internal parasites in mares intended for breeding 
purposes.

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: 
[email protected].

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 7613, filed a supplement to approved NADA 141-215 for EQUIMAX 
(ivermectin 1.87%/praziquantel 14.03%) Paste, used in horses for the 
treatment and control of various species of internal parasites. The 
supplemental NADA provides for use of EQUIMAX Paste in mares intended 
for breeding purposes. In accordance with section 512(i) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(i)) and 21 CFR 
514.105(a) and 514.106(a), the Center for Veterinary Medicine is 
providing notice that this supplemental NADA is approved as of July 30, 
2004. 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 21 CFR 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.
    Under section 512(c)(2)(F)(iii) of the act (21 U.S.C. 
360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing 
exclusivity beginning July 30, 2004.
    The agency 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: August 25, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-20178 Filed 9-2-04; 8:45 am]
BILLING CODE 4160-01-S