[Federal Register Volume 73, Number 111 (Monday, June 9, 2008)]
[Notices]
[Page 32586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1329]
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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:
[email protected].
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