(By Balaseshan) Shire Plc. (NASDAQ:SHPG) said the U.S. regulatory authorities has accepted the filing for review of Vyvanse (lisdexamfetamine dimesylate) capsules for maintenance treatment in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
The U.S. Food and Drug Administration (FDA) has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules.
There are currently no stimulants approved for maintenance treatment in children and adolescents aged 6 to 17 years with ADHD. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2013.
Shire is seeking approval for maintenance treatment in children and adolescents with ADHD based on the results of a clinical study (SPD489-326), a phase 3b, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of efficacy and safety of Vyvanse.
This study was also included in the European Marketing Authorization Application (MAA) submission package for approval of lisdexamfetamine dimesylate in Europe.
Vyvanse is a prescription medication currently approved in the United States for the treatment of ADHD in patients aged 6 to 17 and adults as part of a total treatment plan. The drug is also approved in the United States as a maintenance treatment for adults with ADHD.
SHPG is trading down 0.89% at $91.30 on Wednesday. The stock has been trading between $80.09 and $108.79 for the past 52 weeks.