LuveniqTreatment for Uveitis
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.
Posted: June 2010
- Lux Biosciences Receives Complete Response Letter from FDA for Luveniq - August 10, 2010
- FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq - May 11, 2010
- Lux Biosciences' Luveniq Receives FDA Priority Review - March 30, 2010
- Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis - February 4, 2010