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# FDA Withdraws Approval of 2 Belviq NDAs Due to Safety
- URL: https://www.fdaweb.com/fda-withdraws-approval-of-2-belviq-ndas-due-to-safety/
- Published: 2020-09-17T12:00:00.000Z
- Updated: 2026-09-14T16:29:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147671

*Federal Register* notice: FDA is withdrawing the approval of two Eisai NDAs for Belviq (lorcaserin HCl) tablets and Belviq XR (lorcaserin HCl) extended-release tablets, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adults. In 2019, FDA issued a drug safety communication alerting the public that results from a clinical trial assessing the risk of heart-related problems show a possible increased risk of cancer with both products. On 2/13, FDA announced it had asked Eisai to voluntarily withdraw the drugs from the U.S. market because a safety clinical trial showed an increased cancer occurrence. That same day, Eisai requested that the agency withdraw approval of both NDAs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-17/pdf/2020-20458.pdf?ref=fdaweb.com).