Mallinckrodt questions FDA reasoning on methylphenidate ER reclassification
US drugmaker Mallinckrodt (NYSE:MNK) says it has been informed by the Food and Drug Administration that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release tablets, USP may not be therapeutically equivalent to the category reference drug, Johnson & Jonson’s (NYSE: JNJ) Concerta, a treatment for attention deficit hyperactivity disorder (ADHD) and narcolepsy.
As a result, the agency indicated that it has reclassified Mallinckrodt’s Abbreviated New Drug Application (ANDA 202608) for methylphenidate ER dosage strengths of 27mg, 36 mg and 54 mg from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent).
Decision based on new Draft Guidance
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