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

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

Executive Summary

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?

You may also be interested in...



Tearing Down The Goalposts (Part 2): Diabetes Debate Has Toned Down At US FDA

An October US FDA advisory committee meeting to discuss type 2 diabetes drug cardiovascular safety standards replayed a July 2008 meeting, but in a more harmonious key. That reflects the changing climate for FDA – but also a change in who was invited to participate.

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

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.

US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments

Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS124122

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