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Bioalliance Pharma SA announces FDA approval of Beleodaq


Thursday, 3 Jul 2014 01:58pm EDT 

Bioalliance Pharma SA:Announces that the U.S. Food and Drug Administration (FDA) has granted Topotarget Accelerated Approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).This follows a Priority Review of the Beleodaq New Drug Application (NDA) and was an Early Approval action prior to the Aug. 9, 2014 PDUFA (Prescription Drug User Fee Act) date.Beleodaq was granted marketing authorization under the FDA's accelerated approval program, which allows conditional approval of a medicine for a life-threatening disease based on early evidence suggesting clinical benefit.