FDA affirms five-year NCE exclusivity for Shire's Vyvanse
This article was originally published in Scrip
Executive Summary
Shire's attention deficit/hyperactivity disorder (ADHD) franchise has been given a lift now that the US FDA has affirmed its earlier decision to grant five-year new chemical entity (NCE) exclusivity to Vyvanse (lisdexamfetamine dimesilate) following a challenge by a generic drug maker.