Shire's DAYTRANATM Transdermal Patch Approved by FDA for Treatment of ADHD

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2006-04-07 08:59

Treatment of ADHD

Shire plc announced today that the U.S. Food and Drug Administration (FDA) approved DAYTRANA (methylphenidate transdermal system), the first and only non-oral medication for the treatment of attention deficit hyperactivity disorder (ADHD). DAYTRANA, a once daily transdermal patch formulation of methylphenidate, will be available in 10 mg, 15 mg, 20 mg and 30 mg dosage strengths.

"The approval of DAYTRANA is important news for ADHD patients, their families and healthcare providers. In addition to being the only patch treatment for ADHD, it offers a convenient option to deliver medicine for those diagnosed with ADHD," said Shire Chief Executive Officer Matthew Emmens. "The addition of DAYTRANA to Shire's portfolio reaffirms our position as the market leader in ADHD."

Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application (NDA) for DAYTRANA to the FDA in June of last year. DAYTRANA is licensed globally to Shire by Noven and will be available in pharmacies in the U.S. in mid 2006.

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