Lupkynis
Generic name: voclosporin
Treatment for: Lupus Nephritis
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
Related articles
- FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis - January 22, 2021
- Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis - July 21, 2020
- 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
Lupkynis (voclosporin) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
