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


GSK Will Re-Do Phase II Wellbutrin Metabolite Studies At Higher Dose

This article was originally published in The Pink Sheet Daily

Executive Summary

GlaxoSmithKline will need to re-do its Phase II depression program for its metabolite of Wellbutrin (bupropion) after the 60 mg dose failed to meet the primary endpoint

You may also be interested in...

GSK COX-2 Data Show No Short-Term Cardiovascular Risk, Company Says

Phase II agent has a safety profile similar to that of Celebrex but offers an “incremental” efficacy benefit over Pfizer’s drug, GSK says. NDA filing is tentatively scheduled for late 2006, but timing may depend on outcome of the Feb. 16-17 FDA advisory committee meeting on COX-2 safety issues.

Able Unable To Reform On Its Own? Firm Seeks Consent Decree To Address Manufacturing Issues

“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.





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