Document ID: FDA-2008-N-0039-0049
Agency: fda
Document Type: Rule
Title: Notice of Approval of Supplemental New Animal Drug Application; Moxidectin
Posted Date: 2008-06-09T04:00Z

[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Notices]               
[Page 32586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn08-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Notice of Approval of Supplemental New Animal Drug Application; 
Moxidectin

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 Fort Dodge Animal Health, Division of Wyeth. The approved NADA 
provides for the veterinary prescription use of a sustained-release 
injectable moxidectin formulation for prevention of heartworm disease 
and treatment of existing hookworm infections in dogs. The supplemental 
NADA adds animal safety information to product labeling.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-189 that provides for veterinary prescription use of PROHEART 6 
(moxidectin) Sustained Release Injectable for Dogs, used for prevention 
of heartworm disease and treatment of existing hookworm infections. The 
supplemental NADA updates the warning, precaution, adverse reactions, 
and post-approval experience sections of product labeling. In 
accordance with section 512(i) of the Federal Food, Drug, and Cosmetic 
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 May 23, 2008.
    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.
    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: June 2, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 08-1329 Filed 6-5-08; 12:00 pm]

BILLING CODE 4160-01-S