Inspirion's oxycodone is first immediate-release opioid approved with abuse-deterrent language in labeling.
The US FDA gave its blessing to Inspirion Delivery Sciences LLC's immediate-release (IR) opioid RoxyBond (oxycodone hydrochloride), making it the first IR opioid with abuse-deterrent language in the labeling, but the incorporation of a Risk Evaluation and Mitigation Strategy (REMS) could still be at least a few months away.
The company announced the approval of RoxyBond April 26 with the indication for the management of pain severe enough to require an opioid and
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.
Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.
