🇺🇸 Qulipta in United States

FDA authorised Qulipta on 28 September 2021

Marketing authorisation

FDA — authorised 28 September 2021

  • Application: NDA215206
  • Marketing authorisation holder: ABBVIE
  • Local brand name: QULIPTA
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Qulipta, a medication developed by AbbVie, for the treatment of labeling. This approval was granted through a standard expedited pathway. The application number for this approval is NDA215206.

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Qulipta 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 Qulipta approved in United States?

Yes. FDA authorised it on 28 September 2021.

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

ABBVIE holds the US marketing authorisation.