🇺🇸 FOSCARBIDOPA in United States

FDA authorised FOSCARBIDOPA on 16 October 2024

Marketing authorisation

FDA — authorised 16 October 2024

  • Application: NDA216962
  • Marketing authorisation holder: ABBVIE
  • Local brand name: VYALEV
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

The FDA approved FOSCARBIDOPA, developed by AbbVie, for its approved indication. The approval was granted on 19 March 2026, following a standard expedited pathway. The application number for this approval is NDA216962.

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FOSCARBIDOPA 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 FOSCARBIDOPA approved in United States?

Yes. FDA authorised it on 16 October 2024.

Who is the marketing authorisation holder for FOSCARBIDOPA in United States?

ABBVIE holds the US marketing authorisation.