Shire Receives FDA Approvable Letter for DAYTRANA(TM) for the Treatment of ADHD
Shire Pharmaceuticals (UNITED KINGDOM)
December 23, 2005
PHILADELPHIA, and BASINGSTOKE, England, Dec. 23 /PRNewswire-FirstCall/ -- Shire plc announced today it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for DAYTRANA (methylphenidate transdermal system), an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies. Shire is now initiating dialogue with FDA to address these issues.
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