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Xiidra Approval History

  • FDA approved: Yes (First approved July 11th, 2016)
  • Brand name: Xiidra
  • Generic name: lifitegrast
  • Dosage form: Ophthalmic Solution
  • Company: Shire US, Inc.
  • Treatment for: Dry Eye Disease

Xiidra (lifitegrast) is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease.

Development History and FDA Approval Process for Xiidra

Jul 12, 2016Approval FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease
Feb  4, 2016U.S. FDA Acknowledges Receipt of Resubmission of Shire’s NDA for Lifitegrast for Dry Eye Disease in Adults
Jan 25, 2016Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA
Oct 16, 2015Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial
Apr  9, 2015U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults
Mar  2, 2015Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults
May 16, 2014Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults

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