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FDA Cancels Advisory Committee Meeting for Coclosporin; Priority Review of Lux Biosciences' NDA Continues



6/23/2010 7:28:35 AM

EDMONTON, June 23 /CNW/ - Isotechnika Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has cancelled the Dermatology and Ophthalmology Drugs Advisory Committee review of partner, Lux Biosciences', New Drug Application (NDA) for voclosporin on June 28, 2010.

The meeting was originally planned to provide a forum for FDA Advisors to discuss the data included in Lux's NDA for voclosporin in the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye. The FDA will continue it's priority review of the NDA with the PDUFA date of August 3, 2010.

"The review process in Europe is also underway and expected to be completed by the end of February 2011," stated Dr. Robert Foster, President and CEO of Isotechnika Pharma.

More information on Isotechnika Pharma can be found at www.isotechnika.com or www.SEDAR.com.

We seek Safe Harbour.

For further information

Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., 780-487-1600 (247), 780-484-4105 (fax), rfoster@isotechnika.com Dr. Launa Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., 780-487-1600 (225), 780-484-4105 (fax), laspeslet@isotechnika.com


Read at BioSpace.com


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