Pink Sheet is part 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

Bristol Serzone Status Unchanged In U.S.; Antidepressant Pulled In Europe

Executive Summary

FDA is comfortable with Serzone's current labeling, the agency said following Bristol-Myers Squibb's decision to pull the antidepressant off the market in Europe

You may also be interested in...



Bristol Discontinues Serzone, Stadol And 15 Other Brands; Safety In Numbers?

Bristol will cease distribution of the antidepressant Serzone (nefazodone) effective June 14

Bristol Discontinues Serzone, Stadol And 15 Other Brands; Safety In Numbers?

Bristol will cease distribution of the antidepressant Serzone (nefazodone) effective June 14

Bristol Serzone discussions with Health Canada

Bristol has entered discussions with Canadian regulators over the risk/benefit profile and marketing status of its antidepressant Serzone, the company says. Serzone (nefazodone) has been associated with reports of hepatic failure; the company added a "black box" warning to labeling for the antidepressant in 2001 following 18 reports of liver failure, including 13 deaths (1"The Pink Sheet" Dec. 10, 2001, p. 22). Bristol withdrew Serzone from the market in Europe earlier this year (2"The Pink Sheet" Jan. 13, 2003, p. 23)...

Related Content

UsernamePublicRestriction

Register

PS041074

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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