Arthritis 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: Arthritis 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 February 7, 8, and 9, 2001, 8 a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.

Contact: Kathleen R. Reedy or LaNise S. Giles, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX 301-827-6776, or e-mail reedyk@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12532. Please call the Information Line for up-to-date information on this meeting.

Agenda: On February 7, 2001, the committee will discuss new drug application (NDA) 20-998/S009, Celebrex® (celecoxib, G. D. Searle & Co.) approved for the treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. The discussion is for modification of the label based on the results of the CLASS Trial, a study of the incidence of significant upper gastrointestinal effects. On February 8, 2001, the committee will discuss NDA 21-042/S007, Vioxx^TM (rofecoxib, Merck Research Laboratories) approved for the treatment of signs and symptoms of osteoarthritis and the management of acute pain. The discussion is for changes in the product label related to results of the VIGOR Trial concerning clinical gastrointestinal events. On February 9, 2001, the committee will discuss NDA 20-905/S006, Arava^TM (leflunomide, Aventis) approved for the treatment of active rheumatoid arthritis. The discussion is for an indication to prevent disability as evidenced by improved physical function.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by January 30, 2001. Oral presentations from the public will be scheduled between approximately 11 and 11:30 a. m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 30, 2001, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).