The FDA has informed Dublin-based Mallinckrodt that its generic ADHD drug has been deemed unequal to Johnson & Johnson’s ADHD drug, Concerta.
As a result, the FDA has reclassified Mallinckrodt’s ANDA from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent).
The change follows FDA's recent issuance of new bioequivalency guidance for methylphenidate ER in November 2014.
Mallinckrodt claims that since the product launch in December 2012, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the branded Concerta to the company’s methylphenidate ER products.
Read the Mallinckrodt press release.