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

Antidepressant Relabeling Will Include Pediatric Efficacy Data

Executive Summary

FDA's plan for relabeling antidepressants to address pediatric safety concerns will involve some negotiation with sponsors over how best to present efficacy data

You may also be interested in...



FDA Awaits More Effexor Data Following U.K. Regulatory Changes

FDA is awaiting further data on Wyeth's Effexor following U.K. regulatory changes for the antidepressant

FDA Awaits More Effexor Data Following U.K. Regulatory Changes

FDA is awaiting further data on Wyeth's Effexor following U.K. regulatory changes for the antidepressant

Antidepressant MedGuide

FDA's patient Medication Guide on antidepressants and pediatric suicidality will be available by the end of January, agency says. FDA releases 1proposed MedGuide Nov. 3 with language subject to negotiations with antidepressant drug sponsors; the agency hopes to finalize it by December. The MedGuide is one piece of FDA's plan to alert patients and prescribers to the antidepressant pediatric suicidality risk, which also includes a "black box" warning and unit-of-use packaging (2"The Pink Sheet" Oct. 26, 2004, p. 6). The proposed language generally follows FDA's antidepressant labeling changes, but does point to a potential relationship between antidepressants and violent behavior...

Related Content

UsernamePublicRestriction

Register

PS044851

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