When can one buy Lumateperone in the US and Europe? It is in the Fast Track designation of the FDA since November 2017.
Which country are u from…!!!
What is the new and exciting thing about this med? I don’t know much about it. I know min 101 aims to treat positive and negative symptoms.
The US and European medicine agencies do not work together. Lumateperone is currently only being developed for the US market and the estimated approval/decline is somewhere in 2019.
If Lumaterperone proves to be a (very) potent antipsychotic with minimal side-effects, the company is planning to start a XR version of the drug trials in Europe. So, at this point it’s not even sure if it ever will be available in Europe. Let’s say it does proves to be a innovative drug, we’re talking 3-6 years before it’ll be available in Europe.
The NDA application was just made but it was a partial / rolling application.
The FDA usually approves or disapproves the application 4-10 months after the application is complete.
4-10 months should mean that it is available 2018?
As I indicated, the 4-10 months for USA decision may have not started yet.
When the application is completed, the US FDA will announce a decision date for diasapproval or approval.
Thanks, and do you know when the application will be completed?
The company involved guesses the application will be complete in several months. Its up to them.