KemPharm Seeks FDA Dispute Resolution Over Apadaz's Abuse Deterrence
Sponsor hopes to demonstrate that FDA's process for reviewing extended-release abuse-deterrent opioids may not be appropriate for an immediate-release product. Apadaz would be the first immediate-release opioid with an abuse-deterrent claim if approved.
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Months after reaching agreement with FDA to refile the NDA for its abuse-deterrent opioid Apadaz, KemPharm has gotten the okay to take its prodrug of Ritalin into Phase III for ADHD.
Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.