Shire announced that the 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. The FDA is expected to provide a decision on or around June 20. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months. Launch is planned for the second half of 2017.