New Strength Approved for Narcan Nasal Spray
January 25, 2017 – The U.S. FDA approved Narcan® (naloxone) Nasal Spray as a 2mg dose, manufactured by Adapt Pharma. Previously Narcan was approved as a 4mg strength, which was launched in February 2016, for emergency treatment of known or suspected opioid overdose. The first dose should be given as soon as breathing difficulty or unconsciousness suggests that an overdose has occurred, then emergency help should be contacted immediately. One spray (2mg) should be administered, in opposite nostrils, every two to three minutes until the patient recovers or emergency medical help arrives. To be packaged as two single-dose inhalers per box, Narcan Nasal Spray can be used for both adults and children.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.