🇺🇸 Ravicti in United States

FDA authorised Ravicti on 1 February 2013

Marketing authorisations

FDA — authorised 1 February 2013

  • Application: NDA203284
  • Marketing authorisation holder: HORIZON THERAP US
  • Status: supplemented

FDA

  • Status: approved

Ravicti 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 Ravicti approved in United States?

Yes. FDA authorised it on 1 February 2013; FDA has authorised it.

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

HORIZON THERAP US holds the US marketing authorisation.