positive Phase III results announced 3/09, 4/09, 11/09; NDA filed 2/10; EU accepts MAA 3/10; FDA advisory board to review 6/28/10 (5/10); FDA advisory board canceled 6/28, but priority review granted with 8/3/10 PDUFA date (6/10); Complete response letter received, requesting additional information and a clinical trial (8/10)
Brand Luveniq Generic voclosporin (LX211)
Company name Lux Biosciences, Isotechnika Product type Non-speciality
Therapeutic category Immunologic agents Key uses Uveitis, psoriasis
Other Uses kidney transplant rejection Drug Class calcineurin inhibitor
Dosage From oral Expected Approval 2012+
FDA Filing 2/10 Last Update date August 23,2010
Link to news article
Link to clinicaltrials.gov
Link to press releases