Generics
FDA Accepts Filing of Abbreviated New Drug Application and Grants Priority Review for Nalmefene HCI Injection for the Treatment of Known or Suspected Opioid Overdose
10 June 2021 - - The US FDA has accepted and granted priority review to US-based Purdue Pharma L.P.'s Abbreviated New Drug Application for the vial dosage form of nalmefene hydrochloride injection, the company said.

Injectable nalmefene, an opioid antagonist designed to reverse opioid overdose, may be another treatment option to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids.

Purdue is developing injectable nalmefene in three dosage forms: vial, prefilled syringe and autoinjector.

The nalmefene vial and prefilled syringe are generic forms of a previously approved opioid antagonist.

The nalmefene autoinjector is being developed for use in the community setting by people without medical training.

Use of the nalmefene autoinjector would not replace the need for emergency medical care.

FDA previously granted Competitive Generic Therapy designation for the vial and prefilled syringe and Fast Track designation for the autoinjector.

On March 15, 2021, Purdue announced it filed a Plan of Reorganization. As part of this historic plan, Purdue will be dissolved and its assets will be transferred to a new company upon emergence from Chapter 11.

Purdue Pharma and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.

The company seeks to achieve a global bankruptcy settlement that would deliver more than USD 10bn in value, including 100% of Purdue's assets and millions of doses of opioid addiction treatment and overdose reversal medicines, to communities across the country to fund programs specifically for abatement of the opioid crisis.

The bankruptcy settlement would also deliver funds to private abatement trusts for the benefit of personal injury claimants, the company said.

If Purdue's settlement is approved, Purdue's assets will be transferred to a new company. This new company will be governed by new independent board members, and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis.
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