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# Nipride Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/nipride-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2021-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:51:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148899

*Federal Register* notice: FDA has determined that Exela Pharma Sciences’ Nipride RTU (sodium nitroprusside), 10mg/50mL, was not withdrawn from sale for safety or effectiveness. The determination will allow FDA to approve ANDAs for sodium nitroprusside if all other legal and regulatory requirements are met. The drug is indicated for immediate blood pressure reduction in adult and pediatric patients in hypertensive crises; induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding; and treatment of acute heart failure to reduce left ventricular end- diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance, and mean arterial blood pressure. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-03-16/pdf/2021-05324.pdf?ref=fdaweb.com).