Latest From Esteve Group
Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
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