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

GlaxoSmithKline/Adolor Entereg Resubmission Pushed Out To Third Quarter

This article was originally published in The Pink Sheet Daily

Executive Summary

Response to November “approvable” letter for postoperative ileus NDA will take an additional quarter following an FDA request for more data in the resubmission.

You may also be interested in...



FDA Lets GSK/Adolor Resume Entereg Work

But regulatory hurdles could send GSK on its way, analysts say.

FDA Lets GSK/Adolor Resume Entereg Work

But regulatory hurdles could send GSK on its way, analysts say.

FDA Accepts Adolor/GSK Entereg Resubmission For Postoperative Ileus

Sponsors’ response to FDA clinical holds on the alvimopan program contain “substantially the same” information as the resubmitted NDA, Adolor tells “The Pink Sheet” DAILY.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS066162

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