I have heard the FDA recently denied a citizen petition that sought to suspend the approval of Redux (dexfenfluramine). Why did the FDA deny that request?

0
Posted

I have heard the FDA recently denied a citizen petition that sought to suspend the approval of Redux (dexfenfluramine). Why did the FDA deny that request?

0

A. The citizen petition did not contain any additional medical information that was not already known. The FDA had taken appropriate actions based on the knowledge at that time. Since that time, more information has been obtained that raised enough additional concerns to warrant withdrawal of Redux from the market.

Related Questions