Shire seeks new approval for ADHD drug
PHILADELPHIA — Drug maker Shire is seeking Food and Drug Administration approval for a new usage for a drug used to treat attention deficit hyperactivity disorder, the company said Wednesday.
Shire announced that the FDA had accepted its regulatory approval application for Vyvanse (lisdexamfetamine dimesylate) capsules for maintenance treatment of ADHD in patients ages 6 to 17 years. There currently are no stimulants approved for maintenance treatment of the condition in that age group, Shire said, and the FDA said it would complete its review by April 2013.
The drug currently is approved for treating ADHD in children, adolescents and adults as part of a total treatment plan and is approved as a maintenance treatment for the condition in adults.
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