Posted by Michael Wonder on 28 Dec 2019
Luye Pharma submits new drug application in the U.S. for its anti-depressant drug LY03005
26 December 2019 - Luye Pharma Group has announced submission of a new drug application to the U.S. FDA for LY03005, a new chemical drug for the treatment of major depressive disorder.
It is also the second U.S. FDA new drug application in the central nervous system (CNS) filed by the company.
The application was based on the consensus reached with the FDA under End-Of-Phase 2-CMC meeting and Pre-NDA meeting. LY03005 is an exclusive CNS product developed under Luye Pharma's new chemical/therapeutic entities R&D platform. It is a serotonin-norepinephrine-dopamine triple re-uptake inhibitor, and one of the active metabolites is a serotonin-norepinephrine re-uptake inhibitor.
