19 January 2017 - Shire announced that the U.S. FDA has acknowledged receipt of the Class 2 resubmission of a new drug application for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation.

SHP465 is being evaluated as a potential once-daily treatment for attention deficit hyperactivity disorder (ADHD). The FDA is expected to provide a decision on or around 20 June 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the application for SHP465 in response to the approvable letter from the FDA (18 May 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.

Read Shire press release