The FDA has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP 465, a treatment for ADHD.-Shire plc
Shire plc hs announced that the FDA has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP 465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP 465 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 June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP 465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.
There are patents supporting Shire's overall ADHD franchise in the U.S. that extend to 2029. If approved, Shire expects that SHP 465 will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029. Launch is planned for the second half of 2017.
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