Hyperactivity Information Thread, Horizon scanning: FDA approves VyvanseT (lisdexamfetamine dimesylate) for maintenance of ADHD in adults in H; Source: BioSpace
Area: News
The US Food and Drug Administration (FDA) has approved Vyvanse® (lisdexamfetamine dimesylate) capsules for the maintenance ...
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February 8th, 2012, 9:49 PM
#1
Horizon scanning: FDA approves VyvanseT (lisdexamfetamine dimesylate) for maintenance of ADHD in adults
Source: BioSpace
Area: News
The US Food and Drug Administration (FDA) has approved Vyvanse® (lisdexamfetamine dimesylate) capsules for the maintenance treatment of adults with Attention-Deficit/Hyperactivity Disorder (ADHD). This new approval is additional to the indication for Vyvanse as a treatment for ADHD in patients aged 6 years and above.
The approval is based on results from a six-week phase IV, double-blind, multi-centre, placebo-controlled, randomized withdrawal design study which assessed the maintenance of efficacy and safety of Vyvanse in 123 adults who met DSM-IV-TR® criteria for ADHD.
Following an open-label treatment, in which patients continued to receive the same Vyvanse dose they were taking at study entry, those who maintained treatment re...
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