Shire Adderall XR Sales Suspended In Canada; FDA Stands By “Black Box”
Executive Summary
Differences between FDA and Health Canada's regulatory responses to adverse event reports for Adderall XR are likely to raise more questions about FDA's drug safety review process
You may also be interested in...
ADHD Class Warnings Could Be Strengthened Pending FDA Research
Despite FDA's recent approval of class warning language for attention deficit/hyperactivity disorder treatments, the agency will continue research in an effort to better characterize the extent of stimulant side effects in ADHD patients, Division of Psychiatry Products Director Thomas Laughren indicated
ADHD Class Warnings Could Be Strengthened Pending FDA Research
Despite FDA's recent approval of class warning language for attention deficit/hyperactivity disorder treatments, the agency will continue research in an effort to better characterize the extent of stimulant side effects in ADHD patients, Division of Psychiatry Products Director Thomas Laughren indicated
Shire Daytrana ADHD Patch To Launch In Early July With Some Class Labeling
Shire and manufacturing partner Noven expect an early July launch for Daytrana, the first transdermal patch for the treatment of attention deficit/hyperactivity disorder to receive FDA approval