Isotechnika Pharma Inc. (ISA.TO) announced that the U.S. Food and Drug Administration or FDA has accepted the New Drug Application or NDA for the company's calcineurin inhibitor, voclosporin for priority review. The application was submitted by Isotechnika's partner, Lux Biosciences, Inc.
The FDA granted voclosporin with a priority review status which accelerates the review period to six months. The FDA grants a priority review designation to drugs that are considered to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The target date under the Prescription Drug User Fee Act is August 3, 2010.
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