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... Shire Announces Status of Ongoing FDA Review of NDA for DAYTRANA(TM) for the Treatment of ADHD Shire Announces Status of Ongoing FDA Review of NDA for DAYTRANA(TM) for the Treatment of ADHD PHILADELPHIA, Pennsylvania, and BASINGSTOKE, England, March 10 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S.

Food and Drug Administration (FDA) has confirmed that Shire's resubmission for DAYTRANA in response to information that the FDA requested in its December 23, 2005 approvable letter for DAYTRANA's New Drug Application is being treated as a Class I resubmission.

The review period for Class I resubmissions is 60 days, and since Shire's resubmission was made on February 9, 2006, the anticipated FDA action date is April 9, 2006.

DAYTRANA (methylphenidate transdermal system (MTS)) is 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.

Shire is planning to launch DAYTRANA, if approved, during the first half of 2006.

DAYTRANA is licensed globally to Shire by Noven Pharmaceuticals, Inc.

Notes to Editors SHIRE PLC Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician.

Shire focuses its business on central nervous system, gastrointestinal, general products and human genetic t...

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