Teva Canada Limited announced that Health Canada has approved its application for CACT Methylphenidate ER tablets, the generic version of CConcerta (methylphenidate hydrochloride). This once-daily extended release medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in: Children (6 – 12 years of age); Adolescents (13 – 18 years of age); and Adults (>18 years of age).
Methylphenidate extended release tablets (brand: CConcerta) had annual sales of approximately $175 million in Canada, based on IQVIA sales data as of January 2018. CACT Methylphenidate ER is available immediately to pharmacies across Canada.
"We've heard from healthcare providers, ADHD patients and their parents about the need for an affordable alternative to CConcerta that works in the same way and at the same time," said David Boughner, Senior Director Commercial Management for Teva Canada Limited. "We're pleased to offer patients CACT Methylphenidate ER as a bioequivalent modified release product that allows for a biphasic drug release profile after oral administration. In addition, the pharmacokinetic parameters mimic the concentration-time release profile of CConcerta."
Attention Deficit Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder characterized by inattention, disorganization and/or hyperactivity or impulsivity. ADHD is the most common neurodevelopmental disorder in children, affecting about one in 20 children and is more common in boys than girls. ADHD persists into adulthood for at least 60% of children with the disorder. About 4.5% of adults have ADHD, but most have not been properly diagnosed or treated. ADHD is highly treatable and people with ADHD can function well if they receive effective treatments and interventions.