FDA cancels Advisory Committee review of Lux Biosciences' voclosporin NDA

Jun 24 2010

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.