[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