Scios Natrecor Expanded Mortality Analysis Finds Two New Patient Deaths
This article was originally published in The Pink Sheet Daily
Executive Summary
The J&J subsidiary says the deaths have “no impact on the overall benefit/risk profile” of the heart failure drug when it is prescribed as labeled.
You may also be interested in...
Scios Final Analysis Of Natrecor Trial Finds Two Additional Deaths
Johnson & Johnson subsidiary maintains the additional deaths have “no impact on overall risk/benefit profile” of the heart failure therapy.
Scios Final Analysis Of Natrecor Trial Finds Two Additional Deaths
Johnson & Johnson subsidiary maintains the additional deaths have “no impact on overall risk/benefit profile” of the heart failure therapy.
J&J/Scios Natrecor Labeling Change Includes Expanded Mortality Analysis
FDA does not believe a "Dear Doctor" letter or advisory committee review are warranted at this time. The new labeling reports 30-day and 180-day mortality risks for Natrecor compared to active controls in all randomized trials of the CHF therapy.