When can one buy Lumateperone in the US and Europe? It is in the Fast Track designation of the FDA since November 2017.
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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.
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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.
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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.
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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.
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When the application is completed, the US FDA will announce a decision date for diasapproval or approval.
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Thanks, and do you know when the application will be completed?
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The company involved guesses the application will be complete in several months. Its up to them.
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