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Luveniq Approval Status

  • FDA approved: No
  • Brand name: Luveniq
  • Generic name: voclosporin
  • Company: Aurinia Pharmaceuticals Inc.
  • Treatment for: Uveitis

Luveniq (voclosporin) is a next-generation calcineurin inhibitor intended for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

Development Status and FDA Approval Process for Luveniq

DateArticle
Nov  2, 2016Aurinia Announces Plans for Single Phase III Clinical Trial for Voclosporin in the Treatment of Lupus Nephritis Following Successful Completion of End of Phase II Meeting With FDA
Mar  2, 2016Aurina Receives FDA Fast Track Designation for Voclosporin for the Treatment of Lupus Nephritis
Jun 26, 2014Aurinia Pharmaceuticals Initiates Phase 2b Clinical Trial of Voclosporin to Treat 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

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