US FDA Confirms Luye Pharma’s 505(b)(2) NDA Submission
October 08, 2015 at 09:45 AM EDT
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: // //