NDA filing for Luye Pharma’s antidepressant drug LY03005 accepted by the U.S. FDA (Luye Press Release)
"Luye Pharma Group...announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted the filing of a New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder....Luye Pharma has obtained patents covering the chemical compound, crystal form and formulation of LY03005. The patents relating to the chemical compound and crystal form have been granted in target markets such as China, the U.S., Europe, Japan and Korea."