FDA Refers Wellbutrin SR, Zyban To NIH For Pediatric Studies
FDA is requesting that the National Institutes of Health conduct pediatric studies on GlaxoSmithKline's bupropion agents Wellbutrin SR and Zyban
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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 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