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Luye Pharma Reports Submission of NDA to the US FDA for LY03005

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Luye Pharma Reports Submission of NDA to the US FDA for LY03005

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  • The application is based on the agreement reached with the FDA under End-Of-Phase 2-CMC (EOP2-CMC) & PNDA meeting- marking the second NDA submission to the US FDA in CNS filed by Luye Pharma
  • Luye Pharma has obtained patents covering the chemical compound- crystal form- and formulation of LY03005 in the US- EU- China- Japan and Korea. Additionally- Luye Pharma has filed NDA for its LY03004 to treat schizophrenia and bipolar disorder in Mar’2019
  • LY03005 is an SNDRI & SNRI inhibitor- developed under Luye Pharma's NCE/NTE R&D platform and has the potential to treat major depressive disorder

Click here to­ read full press release/ article | Ref: Businesswire | Image: Facebook


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