Posted from: Sunday, December 11, 2016 - 04:34 PM - Present

New Generic for Concerta

Oct. 21, 2016 - The US FDA approved an AB-rated (therapeutically equivalent) generic for Concerta (methylphenidate). Its AB rating means that the new generic is interchangeable with Concerta, which is manufactured by Janssen.  This approval comes shortly after the FDA announced that it was initiating actions to revoke approval for two extended-release methylphenidate products that are rated BX (presumed therapeutically inequivalent) to Concerta. Mylan, the manufacturer of the new generic for Concerta has not yet released any launch or pricing details. Actavis distributes an authorized generic, which will remain on the market.


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Last Updated Friday, October 11, 2019 - 06:40 PM.