Pfizer announced that the U.S.Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for methylphenidate hydrochloride extended -release chewable tablet (methylphenidate HCI ERCT). The product is being reviewed as a potential new treatment option for Attention Deficit/Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
The product was developed in conjunction with Tris Pharma, a manufacturing partner.
The FDA Prescription Drug User Fee Act (PDUFA) date is December 4, 2015. The NDA demonstrates Pfizer’s continued commitment to patient needs, with the hope of providing another treatment option to help manage the symptoms of ADHD.
