> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Cardene Not Withdrawn Over Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/cardene-not-withdrawn-over-safety-efficacy-fda/
- Published: 2020-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:59:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145908

*Federal Register* notice: FDA has determined that Chiesi USA’s Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for nicardipine hydrochloride injection if all other legal and regulatory requirements are met. Cardene is indicated for short-term treatment of hypertension when oral therapy is not feasible or not desirable. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-23/pdf/2020-01062.pdf?ref=fdaweb.com).