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

publication date: Oct 8, 2015
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)

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