Information about Naloxone
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. In the wake of the opioid epidemic, efforts are underway to make this emergency treatment more readily available and more accessible.
- FDA Approves First Over-the-Counter Naloxone Nasal Spray
- FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use
- FDA Issues Immediately-in-Effect Guidance Regarding Distribution of Approved Naloxone Products
- FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose
- New Recommendations for Naloxone
- Having Naloxone on Hand Can Save a Life During an Opioid Overdose
- Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths
- Naloxone Model DFL With Nasal Spray Placeholder (DRAFT)
- Naloxone Model DFL with Injector Placeholder (DRAFT)
- Comprehension for OTC Naloxone (CONFER) Pivotal Label Comprehension Study - FDA Review of Task 3 Study Report
- FDA approves first generic naloxone nasal spray to treat opioid overdose
- Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
- Joint Meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees
- Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
- CDER’s Division of Nonprescription Drug Products discusses its work to make naloxone, an opioid overdose reversing drug, available over-the-counter
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- 2016 Naloxone App Competition
- Narcan (naloxone nasal spray) Approved to Reverse Opioid Overdose
- Evzio (naloxone auto-injector) Approved to Reverse Opioid Overdose
- Exploring Naloxone Uptake and Use – A Public Meeting (FDA Archive)