FDA approves NDA for generic extended-release Concerta

 ADHD in the News 2017-07-20


Impax Laboratories recently announced receipt of an AB therapeutic equivalent rating and final FDA approval for its abbreviated New Drug Application for a generic version of extended-release Concerta for ADHD. The approved New Drug Application (NDA) is for 18-mg, 27-mg, 36-mg and 54-mg extended-release tablets of generic Concerta (methylphenidate hydrochloride).