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

GSK Handling Of Paxil Data On Pediatric Use Is Subject Of N.Y. Lawsuit

This article was originally published in The Pink Sheet Daily

Executive Summary

The state attorney general alleges that GSK failed to publish information about the safety and efficacy of Paxil in children. The lawsuit seeks disgorgement of profits. GSK maintains that it has publicly communicated the data from its pediatric studies.

You may also be interested in...



FDA ClinicalTrials.gov Report Will Show Growing Rate Of Study Listings

The forthcoming report also will show increased disclosure of company sponsors and drug names in trial descriptions. FDA has added language to IND acknowledgement letters to promote compliance with listing requirements.

FDA ClinicalTrials.gov Report Will Show Growing Rate Of Study Listings

The forthcoming report also will show increased disclosure of company sponsors and drug names in trial descriptions. FDA has added language to IND acknowledgement letters to promote compliance with listing requirements.

GSK Settles With N.Y.; Company Will Post Past Trial Data By End Of 2005

The settlement includes a modest $2.5 mil. disgorgement fee. GSK is also required to advertise the clinical trial register in seven prominent peer reviewed journals.

Related Content

Topics

UsernamePublicRestriction

Register

PS143249

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