PRINCETON, N.J. — The Food and Drug Administration is reclassifying methylphenidate hydrochloride extended-release tablets from Kremers Urban Pharmaceuticals Inc. as the agency seeks more bioequivalence information.
Kremers Urban said Friday that the FDA is requesting an additional bioequivalence study based on recently issued draft guidance to confirm the therapeutic equivalence of the company’s methylphenidate hydrochloride ER tablets (CII), a medication for attention deficit hyperactivity disorder (ADHD), to the category reference drug Concerta from Janssen Pharmaceuticals Inc./Alza Corp.
Pending the additional data, the FDA informed Kremers Urban that it has changed the therapeutic rating for its methylphenidate ER from AB to BX, which means the product is still approved and can be prescribed but isn’t recommended as automatically substitutable at the pharmacy for the brand-name drug.
Kremers Urban said it plans to perform the requested additional study and will work with the agency.
