FDA Panel On Moxduo: Two Opioids Are Not Better Than One
This article was originally published in The Pink Sheet Daily
Anesthetic and Analgesic Drugs Products Advisory Committee unanimously recommends against approval of QRxPharma’s fixed-dose combination of morphine and oxycodone but says exploratory analyses suggesting a reduced risk of deep oxygen desaturation should be tested in a new clinical trial.
You may also be interested in...
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee wants Risk Evaluation and Mitigation Strategies enhanced for all extended-release/long-acting opioids as it recommends 11-2, one abstention, against approval of Zogenix’s single-entity hydrocodone product.
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.
Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.