Trasylol Death Knell: Bayer Withdraws Remaining Product From U.S. Market
Executive Summary
With Bayer removing all remaining supply of Trasylol from hospital pharmacies and warehouses, it seems that the final nail in the coffin for the anti-bleeding agentis being driven home
You may also be interested in...
Bayer Trasylol Being Pulled From Market After BART Trial Fails As Tourniquet
Though Bayer's anti-bleeding drug Trasylol has survived the assault of observational study data and the scrutiny of two joint advisory panels, preliminary data from a randomized controlled trial has finally knocked the drug from the market
Safety Trials In Trasylol ’s Future, But Design Could Prove Challenging
FDA and Bayer will begin discussions of post-marketing studies for the firm's Trasylol (aprotinin) due to suggestive but inconclusive observational data linking the drug to renal events and death
NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications