FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose
Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
- Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
- "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals.
- Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition.
- Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.