Daytrana Safety Issues Remain, Concern Lessened, Reviewer Says In Reversal
Safety issues with Shire/Noven's Daytrana methylphenidate patch remain but the agency's concern about them has been lessened, FDA's clinical reviewer said in a reversal of his written evaluation on the approvability of the attention deficit/hyperactivity disorder product
You may also be interested in...
Post-marketing surveillance and study of skin sensitization with Shire/Noven's Daytrana methylphenidate patch for attention deficit/hyperactivity disorder were recommended by FDA's Psychopharmacologic Drugs Advisory Committee at its Dec. 2 meeting
FDA should be less concerned with statistical significance in evaluating potential safety issues, Office of Drug Safety Associate Director for Science David Graham said Aug. 23
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011