FDA — authorised 23 February 2007
- Marketing authorisation holder: SHIRE DEVELOPMENT
- Status: approved
🇺🇸 Vyvanse in United States
FDA authorised Vyvanse on 23 February 2007
Marketing authorisations
FDA — authorised 15 April 2016
- Application: NDA021977
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 August 2023
- Application: ANDA215415
- Marketing authorisation holder: TEVA PHARMS
- Status: approved
FDA — authorised 25 August 2023
- Application: ANDA217068
- Marketing authorisation holder: ASCENT PHARMS INC
- Status: approved
FDA — authorised 25 September 2024
- Application: ANDA211840
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
The FDA approved Vyvanse for its labelled indication on 25 September 2024. SPECGX LLC is the marketing authorisation holder for the drug. The approval was granted under the standard expedited pathway.
FDA — authorised 29 January 2025
- Application: ANDA218987
- Marketing authorisation holder: GRANULES
- Status: approved
Vyvanse in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Vyvanse approved in United States?
Yes. FDA authorised it on 23 February 2007; FDA authorised it on 15 April 2016; FDA authorised it on 25 August 2023.
Who is the marketing authorisation holder for Vyvanse in United States?
SHIRE DEVELOPMENT holds the US marketing authorisation.