Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for EOquin® (apaziquone for intravesical instillation)

On February 19, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that the U.S. Food and Drug Administration (the "FDA") has accepted the EOquin (apaziquone for intravesical instillation) New Drug Application (NDA) for review (Press release, Spectrum Pharmaceuticals, FEB 19, 2016, View Source [SID:1234509104]).

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The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of December 11, 2016.