August 9-10, 2001


Remodulin™ (treprostinil sodium) Injection, NDA 21-272


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.

United Therapeutics Corporation Presentation:  Efficacy of treprostinil, Stuart Rich, Rush Presbyterian-St. Lukes Medical Center; Safety of treprostinil & Benefit to Risk, Robyn Barst, MD, Columbia Presbyterian Medical Center   ppt    htm

Treprostinil for Pulmonary Hypertension, Regulatory Considerations: Robert Temple, M.D, FDA   ppt   htm

NDA 21-321, Extraneal (7.5% icodextrin) Peritoneal Dialysis solution, for treatment of chronic renal failure

Baxter Healthcare Corporation Presentation:  Introduction and Role of Extraneal: Salim Mujais, M.D.; Clinical Trial Experience with Extraneal: Marsha Wolfson, M.D.,  Frank Ogrinc, Ph.D., Conclusions: Salim Mujais M.D.,    ppt   htm

NDA 21-290, Tracleer (bosentan tablets) for treatment of primary pulmonary hypertension

Actelion, Ltd.  Presentation:  Overview of Efficacy and Safety: Isaac Korbin, M.D.; Drug-induced liver injury: Willis Maddrey, M.D., UT Southwestern Medical Center; Benefit-Risk Assessment: Lewis Rubin, M.D., UCSD   ppt   htm

Actelion, Ltd. Backup Slides   ppt   htm