Posted by Michael Wonder on 18 Jan 2023
FDA grants priority review for nalmefene pre-filled syringe for the treatment of known or suspected opioid overdose
18 January 2023 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new drug application for nalmefene hydrochloride injection 2 mg/2 mL solution in pre-filled syringe.
Earlier last year, Purdue received FDA approval for a vial dosage form of injectable nalmefene hydrochloride. In addition, FDA previously granted competitive generic therapy designation for the pre-filled syringe and the nalmefene hydrochloride injection vial.
