NDA Filing For Luye Pharma’s Antidepressant Drug LY03005 Accepted By FDA

Luye Pharma Group has 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. LY03005 is the company's second drug in the central nervous system (CNS) therapeutic area currently in the U.S. FDA's NDA phase.

LY03005 is an exclusive CNS product developed under Luye Pharma's New Chemical and Therapeutic Entities R&D platform, and is a serotonin-norepinephrine-dopamine triple reuptake inhibitor, with one of the active metabolites being a . . .