BRIEF—Luye Pharma updates on risperidone NDA

China’s Luye Pharma today announced that it has entered the final stage of New Drug Application (NDA) submissions for the innovative drug, risperidone extended release microspheres for injection (LY03004), after previous positive pre-NDA meeting with the US Food and Drug Administration and subsequent related procedures.

Luye had previously requested an NDA number for LY03004 and received a pre-assigned NDA application number (212849) from the FDA in 2018.

The submission dossier for LY03004 is completed and being published in eCTD format according to FDA requirements.

Luye successfully reached an agreement with the FDA to waive all paediatric clinical studies of LY03004, and obtained FDA's approval of using Rykindoas LY03004's brand name for the treatment of schizophrenia or schizoaffective disorder.

The company expects LY03004 will be launched in the USA and China markets by the end of 2019.