Keeping Track: Apadaz Approved Without Abuse-Deterrent Label, FDA Denies Translarna Appeal, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
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Dispute Resolution: Ardelyx Eyes Tenapanor Resubmission Following Successful Appeal To FDA
Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.
Orphazyme’s Sorry Story Ends In Fire Sale
While Orphazyme's attempts to get approval for arimoclomol failed miserably, new owner KemPharm is confident it can get the oral heat shock protein amplifier across the regulatory finishing line for Niemann-Pick disease type C.
US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain
Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.