Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

J&J/Scios Natrecor Labeling Change Includes Expanded Mortality Analysis

This article was originally published in The Pink Sheet Daily

Executive Summary

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.
Advertisement

Related Content

Scios Natrecor Outcomes Study Is Expected To Begin Enrollment In 2007
Scios Natrecor Outcomes Study Is Expected To Begin Enrollment In 2007
Scios Final Analysis Of Natrecor Trial Finds Two Additional Deaths
Scios Final Analysis Of Natrecor Trial Finds Two Additional Deaths
Scios Natrecor Expanded Mortality Analysis Finds Two New Patient Deaths
J&J Natrecor "Dear Doctor" Letter Discusses Appropriate Use In Heart Failure
Natrecor Use Should Be Limited, Independent Panel Convened By J&J Says
Natrecor Safety Confirmed In ADHERE Heart Failure Registry, J&J Says
Natrecor Safety Labeling Change Likely, J&J Says
Natrecor Safety Labeling Change Likely, J&J Says

Topics

Advertisement
UsernamePublicRestriction

Register

PS062046

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel