US FDA Confirms Luye Pharma’s 505(b)(2) NDA Submission

The US FDA confirmed China's Luye Pharma's New Drug Application (NDA) submission via the 505(b)(2) pathway for LY03004 (risperidone). LY03004 is formulated as extended-release injection for the treatment of schizophrenia and/or schizoaffective disorders. The company believes that LY03004 may become the first drug developed by a China company to obtain an FDA NDA approval.  More details.... Stock Symbol: (HK:2186) Share this with colleagues: // //