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# Cardene SR Not Withdrawn Over Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/cardene-sr-not-withdrawn-over-safety-effectiveness-fda/
- Published: 2017-10-30T12:00:00.000Z
- Updated: 2026-09-14T22:58:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139997

*Federal Register* notice: FDA has determined that EKR Therapeutics’ hypertension drug Cardene SR (nicardipine HCl) extended-release capsule (30 mg, 45 mg, and 60 mg) was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the drug product if all other legal and regulatory requirements are met. It was requested by Jubilant Generics in an April citizen petition. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-27/pdf/2017-23438.pdf?ref=fdaweb.com).