A US Food and Drug Administration panel’s review of two opioid-containing products on 15 January suggests sponsors face a high bar in bringing new formulations to market under the agency’s emerging benefit/risk framework for the category.
The anesthetic and analgesic drug products and drug safety and risk management advisory committees overwhelmingly recommended against approval of Intellipharmaceutics International Inc
Although Aximris XR has properties that can be expected to deter abuse by the intravenous route, this benefit was outweighed by evidence suggesting the formulation presents a greater