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09-12-2007 | FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol

September 12, 2007

Committees also recommend further changes to US Label for Trasylol and additional safety studies

Leverkusen, Germany; West Haven, CT, USA, September 12, 2007 — Today, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol® (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery. At the close of the meeting, based on the Trasylol data in Bayer’s controlled clinical studies and after considering data from observational studies and public testimony presented at the meeting, the Committees recommended that US marketing authorization for Trasylol should be continued. Continue reading, ‘09-12-2007 | FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol.’