CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
May 2, 2000
NDA 20-807/S-0004 Refludan [lepirudin (rDNA) for injection]
Cover Memo, Lilia Talarico MD, CDER, FDA
Medical Team Leader's Review, FDA
Statistical Review and Evaluation, FDA
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.
Refludan [lepirudin (rDNA) for injection], Quintiles Inc for Aventis Pharmaceuticals Inc.
Table of Contents
2. Clinical Trial Program for Lepirudin in ACS
3. Dose Finding
4. The Efficacy of Lepirudin Compared to Unfractionated Heparin
5. The Efficacy of Lepirudin Compared to a "Putative Placeabo"
6. The Safety of Lepirudin
7. Risk/Benefit Assessment
8. Summary and Conclusions
9. Literature List