FDA reaffirms Shire exclusivity on attention-deficit-hyperactivity disorder drug

ShireThe FDA has given Shire PLC reaffirmation on a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity. The drug was first approved in 2007 for children between 6 and 12 years old and then again in 2008 for adults. It has competition-free sales until February 23, 2012. GlaxoSmithKline’s sales force is helping in the promotion of the drug in the US.

FDA approves INTUNIV

ShireShire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).