FDA — authorised 13 April 1971
- Marketing authorisation holder: ADAPT
- Status: approved
🇺🇸 Narcan in United States
FDA authorised Narcan on 13 April 1971
Marketing authorisations
FDA — authorised 22 October 1985
- Application: ANDA070298
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 October 1985
- Application: ANDA070299
- Marketing authorisation holder: HIKMA
- Local brand name: NALOXONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 1988
- Application: ANDA071084
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: NARCAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 1988
- Application: ANDA071311
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: NARCAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 1988
- Application: ANDA071083
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: NARCAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 July 2017
- Application: ANDA207634
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 31 October 2018
- Application: ANDA205299
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: REMS
- Status: approved
FDA — authorised 23 April 2024
- Application: ANDA217992
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 12 June 2024
- Application: ANDA207607
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Indication: Labeling
- Status: approved
Mylan Technologies received marketing authorization from the US FDA for Narcan on June 12, 2024. Narcan is a medication used for the emergency treatment of known or suspected opioid overdose. The authorization was granted under the standard expedited pathway.
FDA — authorised 11 February 2026
- Application: NDA208411
- Marketing authorisation holder: EMERGENT
- Indication: Labeling
- Status: approved
The FDA approved Narcan, manufactured by EMERGENT, on 11 February 2026. The approval was granted under the standard expedited pathway, with application number NDA208411. Narcan is indicated for use in accordance with its labelling.
Narcan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Narcan approved in United States?
Yes. FDA authorised it on 13 April 1971; FDA authorised it on 22 October 1985; FDA authorised it on 22 October 1985.
Who is the marketing authorisation holder for Narcan in United States?
ADAPT holds the US marketing authorisation.