FDA Approves Methylphenidate PM Formulation for Pediatric ADHD

 ADHD in the News 2018-08-09

The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for methylphenidate (JORNARY PM) as a therapy for pediatric patients with attention deficit hyperactivity disorder (ADHD). The Ironshore Pharmaceuticals & Development therapy, formerly known as HLD200, is a novel methylphenidate formulation indicated for evening administration in patients with ADHD aged 6 years and older. As a PM therapy, it has shown improvement in the severity of ADHD symptoms in the early morning and throughout the day for patients. Its commercial launch is anticipated in the first half of next year.