The Federal Register

Notice of Approval of Supplemental New Animal Drug Application; Moxidectin

Mon, Jun 9 2008 11:00:00 GMT

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 sustainedrelease 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.

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Mon, Jun 9 2008 11:00:00 GMT

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
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Colesville Rd., Silver Spring, MD, 3015895200.

Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email:
elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512533.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Mon, Jun 9 2008 11:00:00 GMT

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: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices 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 July 15, 2008, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Ronald P. Jean, Center for Devices and Radiological Health (HFZ410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402763676, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512521. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modificatio

Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Psychopharmacologic Drugs

Mon, Jun 9 2008 11:00:00 GMT

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 Committees: Peripheral and Central Nervous System Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee.

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on July 10, 2008, from 8 a.m. to 5 p.m.

Location: Sheraton College Park Hotel, The Ballroom, 4095 Powder Mill Rd., Beltsville, MD, 3019374422.

Contact Person: Yvette Waples, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: yvette.waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washin