Shire methylphenidate patch scheduled for FDA committee review

By Angela McDaniels

Seattle, Oct. 27 - Shire Pharmaceuticals Group plc said the amended new drug application for its methylphenidate transdermal system will be reviewed by the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee at its scheduled open session on Dec. 2.

The system is a transdermal patch designed for once-daily use to treat attention deficit-hyperactivity disorder in children aged 6 to 12 years.

Shire said the application has been assigned a Prescription Drug User Fee Act date of Dec. 28.

Shire Pharmaceuticals Group plc is pharmaceutical company based in Basingstoke, England, that develops products for use in central nervous system, gastrointestinal, renal diseases and human genetic therapies.

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