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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
Advertising
Report Store
UsernamePublicRestriction
Tags:
Drug Approval Standards Drug Safety FDA

The New Zelnorm-al (Part 2): More Thoughts On The Revival Of The 5HT4 Class

  • Analysis

Executive Summary

Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.

You may also be interested in...



The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety

Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?

Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events

In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.


FDA Calls For Pre-Market CV Safety Trials For Some Constipation Drugs

Serotonin receptor 4 agonists for use in constipation have been in limbo due to potential for CV risk; FDA is seeking recommendations about safety studies for the class from an advisory committee.
Table

View full table

Topics

Related Companies

Tags:
Drug Approval Standards Drug Safety FDA
UsernamePublicRestriction

Register

PS124133

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

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