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