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QRxPharma’s Dual-Opioid Therapy MoxDuo Will Face FDA Cmte. Scrutiny

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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