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FDA Flags Generic Versions of ADHD Medication

Yesterday, the Food and Drug Administration (FDA) released a statement concerning the therapeutic benefits of two generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), intended to treat attention-deficit/hyperactivity disorder (ADHD) in adults and children. The agency is asking whether the generic products are bioequivalent to the brand-name drug.The FDA’s inquiry was prompted by an internal reexamination of previously submitted data for the three approved generic versions of Concerta, which included non-brand-name methylphenidate hydrochloride extended-release tablets manufactured by Mallinckrodt Pharmaceuticals, Kudco Ireland Ltd, and Concerta manufacturer Janssen Pharmaceuticals. The results...

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Published By: Psychiatric News - Friday, 14 November, 2014

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