Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

July 19, 2002

NDA 21-188 Omapatrilate Tablets

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.

Background Information, Bristol-Myers Squibb Pharmaceutical Research Institute   pdf

Bibliography   pdf

Food and Drug Administration Briefing Information

Combined Medical/Statistical Review of NDA Resubmission   pdf   htm   doc

Office of Drug Safety Review of Omapatrilat Risk Management Plan  pdf   htm   doc

Summary of Comparative Anti-Hypertensive Trials submitted in Original NDA Submission   pdf    doc

Appendix for Safety Review of Original NDA Submission   pdf   doc