FDA — authorised 3 October 2001
- Status: approved
🇺🇸 Nexplanon in United States
FDA authorised Nexplanon on 3 October 2001
Marketing authorisations
FDA — authorised 27 September 2013
- Application: NDA021529
- Marketing authorisation holder: ORGANON
- Indication: Labeling
- Status: approved
FDA — authorised 4 October 2013
- Application: NDA021187
- Marketing authorisation holder: ORGANON USA ORGANON
- Indication: Labeling
- Status: approved
FDA — authorised 13 January 2021
- Application: ANDA204305
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA — authorised 29 June 2023
- Application: ANDA211157
- Marketing authorisation holder: XIROMED
- Status: approved
FDA — authorised 8 January 2025
- Application: ANDA210830
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
The FDA approved Nexplanon, a contraceptive implant, for marketing by AMNEAL on January 8, 2025. The approval was granted under the standard expedited pathway. Nexplanon is indicated for use in women of reproductive age to prevent pregnancy.
Nexplanon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Nexplanon approved in United States?
Yes. FDA authorised it on 3 October 2001; FDA authorised it on 27 September 2013; FDA authorised it on 4 October 2013.
Who is the marketing authorisation holder for Nexplanon in United States?
Marketing authorisation holder not available in our data.