Yantai's Luye Pharma has filed an NDA in the US for Rykindo®, a novel risperidone extended-release microsphere for injection, which is administered once every two weeks by intramuscular injection to treat schizophrenia and bi-polar disorder. In its clinical trials, Rykindo showed no lag period after the first injection and a steady pharmacokinetic profile. The reference product requires an additional oral drug for the first three weeks of use. Luye claims Rykindo will become the first innovative China drug to receive US FDA approval. More details....
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Original Article: Luye Pharma Files for US Approval of Schizophrenia Treatment