Celgene International Sàrl, a unit of Celgene Corporation(CELG), Thursday announced that the FDA has granted a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.
The FDA grants Priority Review to medicines that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ABRAXANE is set for September 21.
In April 2013, the European Medicines Agency (EMA) has also accepted for review a Type II Variation to the current Marketing Authorization Application (MAA) for ABRAXANE, in combination with gemcitabine, for the first-line treatment of patients with advanced pancreatic cancer.
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