CARDIOVASCULAR & RENAL DRUGS ADVISORY COMMITTEE
August 9-10, 2001
Slides
Remodulin™ (treprostinil sodium) Injection, NDA 21-272
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.
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