Notice on Upcoming FDA Advisory Committee Meeting to Discuss Clinical Data for Aprotinin

Date and Time: The meeting will be held on September 21, 2006, from 8 a.m. to 5 p.m.

Location: Food and Drug Administration, CDER Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD.

Contact Person: Cathy Groupe, 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: 301-827-6778, e-mail: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533 . Please call the information line for up-to-date information on this meeting.

Agenda : The committee will discuss clinical data for aprotinin injection (trade name, TRASYLOL), an approved product, new drug application (NDA) 020-304, Bayer Pharmaceuticals) with the indication for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. This discussion follows a February 8, 2006, FDA Public Health Advisory for the use of aprotinin injection (www.fda.gov/cder/drug/advisory/aprotinin.htm). The background material for this meeting will be posted 1 business day before the meeting.

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 on or before September 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 person 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 on or before September 13, 2006.

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 John Lauttman at least 7 days in advance of the meeting.