Drugmaker Lags In Providing Required Test On Opioid’s Effect On Teens
When Mallinckrodt Pharmaceuticals received approval for a drug called Xartemis XR two years ago, the Food and Drug Administraiton required a study about the effects on teenagers. That study still hasn't been submitted.
Drug Maker Is Warned Over Missing Study About Child Opioids Use
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 .... But as of June 24, the company blew past a March 31 deadline for submitting its pediatric assessment. (Silverman, 7/7)
The CT Mirror:
CT Dems Take Stand On Opioid Funding – And Lose
Democrats drew a line in the sand this week on federal funding to battle opioid addiction and their Republican colleagues blithely walked across it. Despite protests and high drama over the level of money the federal government will spend fighting heroin addiction and prescription pain pill abuse, Democrats lost their battle this week to increase federal funds by nearly $1 billion to pay for additional treatment for addicts. The White House estimated the boost in funding would have provided Connecticut with about $9 million over two years to battle opioid addiction in the state. (Radelat, 7/7)