FDA cancels advisory committee meeting for voclosporin - Priority review of
Lux Biosciences' NDA continues

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.

%SEDAR: 00028600E


For further information: 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

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890