Forum Topic News
  • Conversation: Luye Pharma's Rykindo® Expected to Be the First Chinese Innovative Drug to Receive U.S. FDA Approval

    • March 29, 2019 11:36 AM GMT
    • Luye Pharma's Rykindo® Expected to Be the First Chinese Innovative Drug to Receive U.S. FDA Approval

      Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ("FDA") for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States.
      The NDA submission for Rykindo® is regarded as a milestone step for the company, expecting a big pay-off from the potential industrialization of its long-invested long-acting and extended-release technology R&D platform. This is not only a key step in Luye Pharma's globalization initiative, but also a major step for China in bringing innovative formulations to the world, receiving wide attention from all walks of life.
      Rykindo® is an extended-release microsphere independently developed by Luye Pharma. It is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar disorder.
      Read more: https://prn.to/2YyPfbp

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