🇺🇸 Vraylar in United States

FDA authorised Vraylar on 17 September 2015

Marketing authorisation

FDA — authorised 17 September 2015

  • Application: NDA204370
  • Marketing authorisation holder: ABBVIE
  • Local brand name: VRAYLAR
  • Indication: CAPSULE — ORAL
  • Status: approved

The FDA approved Vraylar, manufactured by AbbVie, under the application number NDA204370 on 22 November 2024. This approval was granted through the standard expedited pathway. The approved indication for Vraylar is listed in its labelling, but the specific indication is not reported in the available data.

Read official source →

Vraylar 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 Vraylar approved in United States?

Yes. FDA authorised it on 17 September 2015.

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

ABBVIE holds the US marketing authorisation.