QRxPharma’s Dual-Opioid Therapy MoxDuo Will Face FDA Cmte. Scrutiny
This article was originally published in The Pink Sheet Daily
FDA told the company there is no precedent for reviewing a combination product that contains two drugs from the same class. The company’s NDA resubmission for the morphine/oxycodone immediate-release product will include oxygen saturation data from a study originally conducted for European regulators.