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# Proposal to Withdraw 5 ANDAs for Lack of REMS
- URL: https://www.fdaweb.com/proposal-to-withdraw-5-andas-for-lack-of-rems/
- Published: 2020-09-24T12:00:00.000Z
- Updated: 2026-09-14T16:30:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147723

*Federal Register* notice: FDA is proposing to withdraw approval of five ANDAs because the application holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy. The notice also announces an opportunity for the ANDA holders to request a hearing on the proposal. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-21186.pdf?ref=fdaweb.com).