August 10, 2001

TRACLEER (bosentan) in Pulmonary Arterial Hypertension

Briefing Information

Actelion Pharmaceuticals Ltd   pdf


The statements contained in this document 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.

FDA Briefing

Secondary Medical Review   pdf   htm

Medical Review of Safety and Efficacy Conclusions   pdf   htm

Medical Review of Safety   pdf   htm

Medical Review of Efficacy   pdf  htm

Statistical Review and Evaluation Amendment   pdf   htm

Statistical Review and Evaluation   pdf   htm

Overall Summary and Evaluation of Preclinical Pharamcodynamics, Toxicokinetics and Toxicology   pdf   htm

Biopharmaceutics Review   pdf   doc