FDA accepts filing of abbreviated new drug application and grants priority review for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose

Purdue Pharma

10 June 2021 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new drug application for the vial dosage form of nalmefene hydrochloride injection.

FDA previously granted competitive generic therapy designation for the vial and pre-filled syringe and fast track designation for the auto-injector.

Read Purdue Pharma press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier