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Spectrum Pharmaceuticals, Inc. (SPPI) Announces FDA’s Acceptance Of NDA Filing For Beleodaq™ (Belinostat) For Injection, A Novel Pan-HDAC Inhibitor


2/6/2014 8:38:11 AM

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HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, announced today that its New Drug Application (NDA) for Beleodaq, a novel, pan-histone deacetylase (HDAC) inhibitor, has been accepted for filing by the U.S. Food and Drug Administration (FDA). FDA establishes review classification for this application as Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 9, 2014. Spectrum is seeking FDA approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).

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