CARDIOVASCULAR & RENAL DRUGS ADVISORY COMMITTEE
May 25, 2001
Natrecor (nesiritide) for Injection NDA 20-920
Scios Inc.
Disclaimer
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.
Briefing Document pdf
Cover letter for Briefing Document from January 29, 1999 meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf
Briefing Document from January 29, 1999 meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf
Food and Drug Administration
Combined Medical & Statistical Review, February 26, 1999 pdf
Medical Review pdf
Medical Review Addendum pdf
Statistical Review pdf
Statistical Addendums
Addendum #1 pdf
Addendum #2 pdf
Addendum #3 pdf
Addendum #4 pdf