🇺🇸 VYKAT XR in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised VYKAT XR on 26 March 2025

Marketing authorisation

FDA — authorised 26 March 2025

Application: NDA216665
Marketing authorisation holder: SOLENO THERAP
Local brand name: VYKAT XR
Indication: TABLET, EXTENDED RELEASE — ORAL
Status: approved

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Frequently asked questions

Is VYKAT XR approved in United States?

Yes. FDA authorised it on 26 March 2025.

Who is the marketing authorisation holder for VYKAT XR in United States?

SOLENO THERAP holds the US marketing authorisation.