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# Zofran Not Withdrawn Over Safety/Efficacy
- URL: https://www.fdaweb.com/zofran-not-withdrawn-over-safety-efficacy/
- Published: 2023-10-16T12:00:00.000Z
- Updated: 2026-09-14T19:02:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155570

*Federal Register* notice: FDA has determined that Sandoz’s Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not withdrawn due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. Zofran ODT is indicated for preventing nausea and vomiting associated with cancer chemotherapy and radiotherapy. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-22844.pdf?ref=fdaweb.com).