- The FDA has acknowledged receipt of Shire plc's (NASDAQ:SHPG) Class 2 resubmission of its New Drug Application (NDA) seeking approval of SHP465 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The action (PDUFA) date should be on or around June 20. A Class 2 resubmission provides for a six-month review.
- It has been a long haul for SHP465. The original NDA was submitted in July 2006. In May 2007, the agency send an Approvable Letter to the company requesting additional clinical studies and classified the resubmission as Class 2. The updated application includes data from 16 clinical studies involving over 1,600 subjects.
- SHP465 [triple-bead mixed amphetamine salts (MAS)] is an oral stimulant medication under development for the treatment of ADHD. It is designed to control symptoms up to 16 hours.