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Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee

Agenda :
The committees will consider the safety and efficacy of new drug application (NDA) 21-887, proposing over-the-counter (OTC) use of ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)), GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in overweight adults when used along with a reduced calorie and low fat diet.

Background material and meeting information will become available no later than one business day before the meeting.

Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. Written may be made to the contact person by January 13, 2006. 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 before January 13, 2006, and submit a brief statement of the general nature of the information 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 Darrell Lyons (see Contact Person) at least 7 days in advance of the meeting.

Contact Person:
Darrell Lyons, 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, e-mail: lyonsd@cder.fda.gov.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 3014512541 or 3014512536.