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# FDA Withdraws Approval of Vintage Pharma ANDA
- URL: https://www.fdaweb.com/fda-withdraws-approval-of-vintage-pharma-anda/
- Published: 2023-06-06T12:00:00.000Z
- Updated: 2026-09-14T18:36:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154618

*Federal Register* notice: FDA is withdrawing approval of a Vintage Pharmaceuticals ANDA for pemoline tablets in response to the sponsor’s request. All pemoline product sponsors stopped marketing their products in 2005 due to an FDA safety alert that concluded the overall liver toxicity risk of Cylert (pemoline) and associated generics )outweighed the benefits of the products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-06-06/pdf/2023-11991.pdf?ref=fdaweb.com).