FDA Advisory Committee Briefing Document

Joint meeting of the

Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee

September 12, 2007

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).

FDA Briefing Material (pdf)

Bibliography (pdf)

Bayer HealthCare Pharmaceuticals

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Trasylol® (Aprotinin Injection), Bayer HealthCare Pharmaceuticals

Briefing Material (pdf)