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FDA Pushing Forward With Withdrawal Of Two Concerta Generics

 
• By Michael Cipriano

Mallinckrodt and Kremers seem prepared to fight formal notice, which comes almost two years after FDA found their methylphenidate generics failed to demonstrate bioequivalence to the Janssen's brand drug.

FDA entrance sign 2016

Mallinckrodt PLC and Kremers Urban Pharmaceuticals Inc. could be gearing up for a fight with FDA, after the agency proposed withdrawing approval for the firms' generic forms of Janssen Pharmaceuticals Inc.'s ADHD medication Concerta (methylphenidate).

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