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.
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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.
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.
‘Frontline’ Essential Workers, Persons 75 Years And Older Prioritized For Second Phase Of COVID Vaccination
Essential workers who cannot work remotely and have high levels of interaction with the public, and individuals ≥75 years old, should get vaccinated ahead of those 65-74 years old and those with comorbid conditions, CDC Advisory Committee on Immunization Practices recommends.