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

 
• By Michael McCaughan

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.

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The US FDA's Gastrointestinal Drugs Advisory Committee vote supporting the relaunch of the irritable bowel syndrome therapy Zelnorm (tegaserod) is a milestone event in the Gottlieb-era at the agency.

It is an almost self-conscious effort by FDA to declare the “Safety First” era that defined regulatory decisions a decade...

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