FDA formally accepts new NDA drug application for leppelzone reprieve microsphere Rykindo for green leaf pharmaceutical injection
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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Green leafPharmaceutical(http://the group's independent lying innovative formulation, injection lipotone slow-release microsphere Rykindo (LY03004) is one step closer to being approved for listing in the United States, the U.SFoodMedicines(http://Regulatory Authority (
FDA(http://has completed a volume review to formally accept Rykindo's NDAnew drug(http://applicationRykindo's NDA acceptance is the first innovative formulation accepted by the FDA by chinese pharmaceutical companies, and also means that China's first self-developed microsphereproduct (http:// will enter the U.S market in the near future Rykindo's upcoming dose, containing 12.5 mg, 25 mg, 37.5 mg, and 50 mg of lipeone, is given every two weeks by intramuscular injection to treat schizophrenia and bipolar disorder With the launch of Rykindo, it is hoped that oral antipsychotic drug (http:// will be prevalent in patients and can optimize clinical treatment options In addition, rykindo is free to take oral preparations three weeks after the first injection, and can reach steady-state blood concentrations more quickly, providing patients with new treatment options, compared to another listed product Rykindo's large population of patients in the field of central neuromedicine is also a key point of growth for the next phase of Greenleaf Pharmaceuticals' business, and for this company's (http:// a long-term strategic layout of the product line in the field more than a decade ago in addition to Rykindo, a number of new drugs have entered the clinical late stage in China and overseas, including the treatment of Parkinson's disease injection rothegoting reprieve microsphere (LY03003) has entered phase III clinical in China and the United States, and in Japan to carry out Phase I clinical trial (http:// ; 005) has entered Phase III clinical in China, entering the critical clinical stage in the United States, Liss's Mindo Day Patch (LY30410) has completed critical trials for the treatment of Alzheimer's disease in Germany, and palofoxaketone reprieve fluid injection (LY03010) for the treatment of schizophrenia and schizophrenic emotional disorders has also been developed simultaneously in China and overseas
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