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Antiviral Drugs Advisory Committee

Agenda:
The committee will discuss new drug applications (NDAs) 21-797 and 21-798, entecavir tablets and entecavir oral solution, respectively, Bristol-Myers Squibb Co., proposed for the treatment of patients with chronic hepatitis B infection (HBV).

Background material and meeting information will become available no later than one business day before the meeting (Simply select the appropriate committee link).

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 February 25, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 25, 2005, 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. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Angie Whitacre at 301-827-7001 at least 7 days in advance of the meeting.

Contact Person:
Anuja Patel, Food and Drug Administration, Center for Drug Evaluation and Research (HFD-21), 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, Maryland 20857, 301-827-7001, Fax: 301-827-6776, e-mail: PatelA@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512531. Please call the Information Line for up-to-date information on this meeting.