Popular Articles From: Mallinckrodt plc Responds to FDA’s Expected Reclassification of Methylphenidate ER to Lebenthal Wealth Advisors Selects FolioDynamix for Turnkey Asset Management Platform


Mallinckrodt plc (NYSE: MNK) has been informed by the U.S. Food and Drug Administration (FDA) that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release (ER) tablets, USP (CII) may not be therapeutically equivalent to the category reference drug Concerta®. As a result, the agency indicated that it has reclassified Mallinckrodt’s 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). The agency said that this change was based on the application of its new Draft Guidance for determining bioequivalence of methylphenidate hydrochloride products just published on November 6, 2014.
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Popular Articles From: Mallinckrodt plc Responds to FDA’s Expected Reclassification of Methylphenidate ER to Lebenthal Wealth Advisors Selects FolioDynamix for Turnkey Asset Management Platform
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