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# Ortho-Cept Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/ortho-cept-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2021-08-20T12:00:00.000Z
- Updated: 2026-09-14T17:11:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149976

*Federal Register* notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDAs that reference the drug product, and it will allow the agency to continue to approve related ANDAs if they meet relevant legal and regulatory requirements. Ortho-Cept is indicated for preventing pregnancy. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-17990.pdf?ref=fdaweb.com).