Shire Daytrana "complete response"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Shire development partner Noven completes a Class 1 "complete response" to FDA's December 2005 "approvable" letter for the firms' attention deficit hyperactivity disorder patch Daytrana (methylphenidate transdermal system), Noven says March 6. If accepted for review, Daytrana could be approved in May. Noven began inventory production of Daytrana in mid-December in anticipation of a mid-year launch. Daytrana had been deemed "not approvable" by FDA in April 2003; a response to that letter was submitted in June 2005 (1Pharmaceutical Approvals Monthly August 2005, In Brief)...