🇺🇸 VYEPTI in United States

FDA authorised VYEPTI on 21 February 2020

Marketing authorisation

FDA — authorised 21 February 2020

  • Application: BLA761119
  • Marketing authorisation holder: Lundbeck Seattle BioPharmaceuticals, Inc.
  • Local brand name: VYEPTI
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved VYEPTI, a drug developed by Lundbeck Seattle BioPharmaceuticals, Inc., on 22 October 2025. The approval was granted under the standard expedited pathway. The indication for which VYEPTI was approved is efficacy, but the specific condition or disease it treats is not specified in the available information.

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VYEPTI 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 VYEPTI approved in United States?

Yes. FDA authorised it on 21 February 2020.

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

Lundbeck Seattle BioPharmaceuticals, Inc. holds the US marketing authorisation.