> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Proposes Withdrawal of Mallinckrodt’s Generic Concerta
- URL: https://www.fdaweb.com/fda-proposes-withdrawal-of-mallinckrodts-generic-concerta/
- Published: 2016-10-18T12:00:00.000Z
- Updated: 2026-09-14T21:40:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137111

*Federal Register* Notice: FDA has proposed to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is announcing an opportunity for the holder of the ANDA, Mallinckrodt Pharmaceuticals, to request a hearing. After receiving adverse event reports, FDA determined there was an insufficient therapeutic effect of the Mallinckrodt’s product. A new bioequivalence study sponsored by FDA found that the product failed to meet the criteria for bioequivalence recommended by the agency in an updated guidance. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-10-18/pdf/2016-25093.pdf?ref=fdaweb.com).