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# Lupron Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/lupron-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-05-30T12:00:00.000Z
- Updated: 2026-09-15T01:29:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144217

*Federal Register* notice: FDA has determined that AbbVie’s Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. Lupron is indicated for palliative treatment of advanced prostatic cancer. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-30/pdf/2019-11243.pdf?ref=fdaweb.com).