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# Gynorest Not Withdrawn Due to Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/gynorest-not-withdrawn-due-to-safety-effectiveness-fda/
- Published: 2017-09-06T12:00:00.000Z
- Updated: 2026-09-14T22:47:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139563

*Federal Register* notice: FDA has determined that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference Gynorest if all other legal and regulatory requirements are met. The product was initially approved in 1978 for amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. However, Solvay never marketed the product. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-06/pdf/2017-18816.pdf?ref=fdaweb.com).