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Two Concerta Generics Lose Therapeutic Equivalency Rating

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA downgrades Mallinckrodt and Kudco’s methylphenidate generics from AB- to BX-rated. An influx of patient complaints about lack of efficacy spurred an investigation of the products and subsequent revision of the agency’s draft bioequivalence guidelines for the ADHD drug.

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