Collegium Targets Remoxy ER Through Citizen Petition Process – Again
Citizen petition resembles July 2016 petition targeting extended-release oxycodone products, but this time names the products it's worries about.
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Agency reviewers see lower potential for intranasal abuse with Pain Therapeutics' extended-release opioid compared to immediate-release oxycodone, but an increased abuse potential when Remoxy is chewed compared to swallowing the drug intact.
Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
FDA's complete response letter includes extensive list of new studies needed to support abuse-deterrence claims not featured in two prior CRLs, Pain Therapeutics says, wondering why the agency is only now raising issues that could have been discussed previously.