FDA Refers Wellbutrin SR, Zyban To NIH For Pediatric Studies
Executive Summary
FDA is requesting that the National Institutes of Health conduct pediatric studies on GlaxoSmithKline's bupropion agents Wellbutrin SR and Zyban
You may also be interested in...
Wellbutrin SR Generics Multiply As Andrx Relinquishes Exclusivity
Andrx' agreement to give up its first-to-file ANDA exclusivity on a generic of GlaxoSmithKline's Wellbutrin SR 150 mg tablet means six companies will immediately share in the profits on sales of the generic antidepressant
FDA Requests Antidepressant Labeling Add Suicidality Warning
FDA is requesting that labeling for 10 antidepressants include a warning recommending close monitoring of adult and pediatric patients for suicidal behavior
Pediatric Off-Patent Study Requests Will Not Mirror Rate For Exclusivity
FDA does not expect to issue written requests for studies of off-patent drugs at the same rate it has for patented drugs seeking pediatric exclusivity, Office of Counterterrorism & Pediatric Drug Development Director Dianne Murphy, MD, said