Shire Comments on USPTO Petitions Related to LIALDA and GATTEX
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Shire plc (SHPG), FDA Reach Agreement on Regulatory Path for SHP465
April 7, 2015 5:57 AM EDTShire plc (NASDAQ: SHPG) announces that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts - MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.
Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD (ages 6-17). While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the... More
