Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Hikma Pharma’s (LON: HIK) Revex (nalmefene). Nalmefene is utilized to reverse the effects of opioid drugs, including respiratory suppression caused by natural or synthetic opioids, or to address known or suspected opioid overdoses.
Nalmefene, first approved for marketing in the United States in April 1995, saw its first generic approval in February 2022, with the original marketing authorization held by Purdue Pharma LP, which has since ceased operations. Easton Pharma’s product becomes the second generic nalmefene approved in the US, available in specifications including 0.1mg/1mL and 2mg/2mL.
Clinical data indicates that nalmefene has a longer duration of action and relatively fewer side effects when reversing respiratory depression associated with acute opioid overdose.- Flcube.com
