Notice of Approval of Supplemental New Animal Drug Application; Moxidectin, 32586 [08-1329]

Download as PDF 32586 Federal Register / Vol. 73, No. 111 / Monday, June 9, 2008 / Notices Analysis and Services Office, CDC pursuant to Public Law 92–463. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Ms. Amy Harris, Executive Secretary, ACIPC, NCIPC, CDC, 4770 Buford Highway, NE., M/ S F–63, Atlanta, Georgia 30341–3724, telephone (770) 488–4936. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 3, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8–12892 Filed 6–6–08; 8:45 am] Services Office, Centers for Disease Control and Prevention, pursuant to Section 10(d) Public Law 92–463. Matters To Be Discussed: The meeting will convene to address matters related to the conduct of Study Section business and to consider Safety and Occupational HealthRelated Grant Applications. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Price Connor, PhD, NIOSH Health Scientist, 1600 Clifton Road, NE., Mailstop E–20, Atlanta, Georgia 30333, Telephone (404) 498–2511, Fax (404) 498–2571. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 30, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8–12793 Filed 6–6–08; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention BILLING CODE 4163–18–P Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health, (NIOSH) DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on PROD1PC66 with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Times and Dates: 8 a.m.–5 p.m., June 26, 2008 (Closed); 8 a.m.–5 p.m., June 27, 2008 (Closed). Place: Embassy Suites Hotel, 1900 Diagonal Road, Alexandria, Virginia 22314, Telephone (703) 684–5900, Fax (703) 684– 1403. Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute’s standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broadbased research endeavors in keeping with the Institute’s program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to support more focused research projects, which will lead to improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funded will promote these program goals. These portions of the meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and VerDate Aug<31>2005 18:05 Jun 06, 2008 Jkt 214001 Food and Drug Administration Notice of Approval of Supplemental New Animal Drug Application; Moxidectin AGENCY: Food and Drug Administration, HHS. ACTION: 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 Notice. 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, email: 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 PO 00000 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. Frm 00039 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on June 25, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, Maryland Ballroom, 8727 E:\FR\FM\09JNN1.SGM 09JNN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.