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Purdue Pharma obtains FDA approval for Nalmefene

Nalmefene, expected to be available by mid-2022, is indicated for the complete or partial reversal of opioid drug effects.

Purdue Pharma has obtained the Food and Drug Administration’s clearance for nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL).

Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.

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The company will be distributing injectable nalmefene for no profit.

“Nalmefene is an important part of our commitment to help abate the opioid crisis,” Craig Landau, CEO and president, Purdue Pharma, said. “This FDA approval is an example of our ongoing efforts to help provide much-needed treatment for patients and health care providers. Nalmefene will be an important treatment option to address the opioid crisis, which has accelerated during the COVID-19 pandemic and is being fueled by the increasing prevalence of illicitly manufactured synthetic opioids.”

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Purdue Pharma's Nalmefene is intended to be used by healthcare professionals in emergency departments. It is expected to be available by mid-2022.

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