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Two Concerta Generics Lose Therapeutic Equivalency Rating

 
• By Sue Sutter

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.

Mallinckrodt AG and Kudco Ireland Ltd. must demonstrate that their generic versions of Janssen Pharmaceuticals Inc.’s attention deficit/hyperactivity disorder drug Concerta (methylphenidate extended-release) meet new bioequivalence requirements within six months or face withdrawal of their products from the market.

In an action announced Nov. 13, FDA said that due to questions about whether Mallinckrodt and Kudco’s generics are bioequivalent...

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