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# Bayer’s Revex Not Withdrawn Due to Safety/Effectiveness
- URL: https://www.fdaweb.com/bayers-revex-not-withdrawn-due-to-safety-effectiveness/
- Published: 2017-11-03T12:00:00.000Z
- Updated: 2026-09-14T22:59:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140048

*Federal Register* notice: FDA has determined that Bayer’s Revex (nalmefene hydrochloride injection), which is indicated for reversing an opioid overdose, was not withdrawn due to safety or effectiveness issues. This determination will allow the agency to approve ANDAs referencing the product as long as other legal and regulatory requirements are met. The notice is in response to a citizen petition submitted in March by Nirsum Pharmaceuticals.