Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Lotronex Letter Cites Desire To Work With Glaxo To Maintain Therapy

Executive Summary

FDA is willing to continue working with Glaxo Wellcome on a risk management program for Lotronex, the agency said in a Dec. 18 letter to consumers.

You may also be interested in...



GSK Lotronex Limited-Access Program Revisited By FDA In Patient Letter

FDA is revisiting the dispute over a limited-access program for GlaxoSmithKline's withdrawn irritable bowel syndrome drugLotronex

GSK Lotronex Limited-Access Program Revisited By FDA In Patient Letter

FDA is revisiting the dispute over a limited-access program for GlaxoSmithKline's withdrawn irritable bowel syndrome drugLotronex

Lotronex Risk Factor Identification Is Prerequisite To Return, FDA Says

GlaxoSmithKline and FDA are discussing ways to identify risk factors for Lotronex adverse events as a foundation for a risk management plan for the irritable bowel syndrome therapy.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS037095

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