FDA has concerns over bioequivalence of two Concerta generics

After analyzing bioequivalence data, the FDA has issued an alert that two generic versions of Concerta (methylphenidate hydrochloride) made by Mallinckrodt and Kudco, may not be therapeutically equivalent to the brand-name product.

The FDA has not identified any serious safety concerns with these products, despite concerns about lack of therapeuticm equivalence.

The FDA is urging patients to consult with their doctors about lack of therapeutic efficacy if they are having problems.