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Luveniq Approval Status

  • FDA approved: No
  • Brand name: Luveniq
  • Generic name: voclosporin
  • Company: Lux Biosciences, 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.

In August 2010, Lux Biosciences, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Luveniq had not been approved.

Development Status and FDA Approval Process for Luveniq

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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