Shire says FDA confirms resubmission of Daytrana application

By Ted A. Knutson

Washington, March 10 - Shire plc said the Food and Drug Administration will treat as a class 1 resubmission the company's response to information that the FDA requested in its Dec. 23 approvable letter for the New Drug Application for Daytrana.

The review period for class 1 resubmissions is 60 days, and since Shire's resubmission was made on Feb. 9, the anticipated FDA action date is April 9.

Daytrana (methylphenidate transdermal system) is an investigational transdermal patch formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder in children aged six to 12 years. Shire is planning to launch Daytrana, if approved, during the first half of 2006.

Shire, based in Basingstoke, England, is a specialty pharmaceutical company.

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