As the nation grapples with opioid abuse and misuse, one drug maker has failed to provide the Food and Drug Administration with a required study about the effect its powerful painkiller might have on teenagers.
At issue is Xartemis XR, which Mallinckrodt Pharmaceuticals received regulatory approval to sell two years ago. At the time, the company was also required to conduct a so-called postmarketing study to determine its safety in youngsters between 12 and 17 years old, according to FDA documents (see page 11).
At issue is Xartemis XR, which Mallinckrodt Pharmaceuticals received regulatory approval to sell two years ago. At the time, the company was also required to conduct a so-called postmarketing study to determine its safety in youngsters between 12 and 17 years old, according to FDA documents (see page 11).
