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.
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.
