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Lupkynis FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

FDA Approved: Yes (First approved January 22, 2021)
Brand name: Lupkynis
Generic name: voclosporin
Dosage form: Capsules
Company: Aurinia Pharmaceuticals Inc.
Treatment for: Lupus Nephritis

Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).

Development timeline for Lupkynis

Jan 22, 2021Approval FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis
Jul 21, 2020Aurinia 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
Aug 10, 2010Lux Biosciences Receives Complete Response Letter from FDA for Luveniq
Jun 23, 2010FDA cancels advisory committee meeting for voclosporin - Priority review of Lux Biosciences ' NDA continues
May 11, 2010FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq
Mar 30, 2010Lux Biosciences' Luveniq Receives FDA Priority Review
Feb  4, 2010Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis

Further information

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