FDA Neonatology Strategic Plan Should Focus On Commonly Used NICU Drugs
In its first meeting, the neonatology subcommittee of FDA’s Pediatric Advisory Committee discusses challenges to studying therapeutics in infants during their first month of life and strategies for getting more neonatal-specific information about commonly used drugs into labeling.
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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.
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.