Spectrum Pharmaceuticals announces FDA's acceptance of NDA filing for EOquin
Spectrum announced that the U.S. Food and Drug Administration (the "FDA") has accepted the EOquin® (apaziquone for intravesical instillation) New Drug Application (NDA) for review.
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The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA.
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The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of December 11, 2016.