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

Solvay Expects Advisory Cmte. Review For Irritable Bowel Agent Cilansetron

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Gastrointestinal Drugs and Drug Safety & Risk Management Advisory Committees are expected to discuss cilansetron at a March 9 joint meeting. The agency extends the Jan. 1 user fee deadline for the NDA by 90 days to April 1.

You may also be interested in...



Solvay Preparing Announcement On Cilansetron NDA

Solvay receives a response letter from FDA one week ahead of the user fee deadline for the irritable bowel syndrome product. Solvay is currently assessing the letter's contents, the company says.

Solvay Preparing Announcement On Cilansetron NDA

Solvay receives a response letter from FDA one week ahead of the user fee deadline for the irritable bowel syndrome product. Solvay is currently assessing the letter's contents, the company says.

Solvay Picks Up Tricor Franchise Through Acquisition Of Fournier Pharma

Fournier's co-marketing agreement with Abbott for the lipid-lowering product will remain unchanged following Solvay's €1.3 bil. acquisition of the French company. Solvay will build a new cardio-metabolic division from Fournier, to be headquartered in Paris.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS058445

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