FDA authorised Ingrezza on 22 November 2024
The FDA approved Ingrezza, developed by Neurocrine, for its approved indication. This approval was granted through a standard expedited pathway. The application number for this approval is NDA209241.
The FDA approved Ingrezza, a drug developed by Neurocrine, for its approved indication. This approval was granted on 8 April 2026, following a standard expedited pathway. The application number for this approval is NDA218390.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 22 November 2024; FDA authorised it on 8 April 2026; FDA has authorised it.
NEUROCRINE holds the US marketing authorisation.