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

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<http://www.isotechnika.com> or www.SEDAR.comhttp://www.SEDAR.com.

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.