23 June 2022 - - Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL) is now available in the US for use by healthcare professionals, US-based Purdue Pharma L.P. said.

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.

In February 2022, FDA approved Purdue's abbreviated new drug application for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose with natural or synthetic opioids.

FDA had previously granted Competitive Generic Therapy (CGT) designation for the nalmefene hydrochloride injection vial.

With CGT designation and recent FDA approval, Purdue is eligible for 180 days of market exclusivity for nalmefene hydrochloride injection. However, the company will not exercise this option. Additionally, Purdue will distribute nalmefene for no profit.

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

Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.