Posted by Michael Wonder on 08 Nov 2017
Collegium receives FDA approval for sNDA for Xtampza ER
7 November 2017 - Comparative OxyContin data and oral human abuse deterrent claim added to label.
Collegium Pharmaceutical announced today that the U.S. FDA approved its Supplemental New Drug Application (sNDA) to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
