FDA approves Pfizer Ruxience for adult patients to treat a wide range of diseases
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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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recently, Pfizer announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved Ruxience (rituximab-pvvr, ritusxixipro, rituxixixim) for the treatment of adult patients: non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), granuloma with polyheonitis (GPA), micromysis (MPA)Ruxience is the bio-
pharmaceutical(http://of Roche-branded drug Rituxan, the first bio-biosimilar approved by the FDAIn November 2018, Truxima (rituximab-abbs, rituxixixim), developed by Celltrion and Teva, received FDA approval, becoming the first litoxic monogeneric drug approved by the U.SmarketThis approval is based on a review of a comprehensive packet that demonstrates the similarity between Ruxience and referenceproduct(http://This includes the results of a clinical comparative study of REFLECTIONS B3281006, conducted in CD20-positive patients with low tumor burden lifsaroma (FL), assessed Ruxience's efficacy, safety and immunoogenics, pharmacokinetics, and pharmacodynamics, and found no clinical differences in safety and efficacy compared tocontrol(http://
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