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

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

UsernamePublicRestriction

Register

PS066162

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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