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.

Cover Letter

Table of Contents

1. Introduction

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

Appendix A