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Monday, September 10, 2018 1:49:05 PM
https://www.federalregister.gov/documents/2017/11/03/2017-23952/determination-that-revex-nalmefene-hydrochloride-injection-01-milligram-basemilliliter-and-10
"After considering the citizen petition (and comments submitted to the docket) and reviewing Agency records, and based on the information we have at this time, FDA has determined under §?314.161 that REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness."
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