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Lifitegrast Approval Status

  • FDA approved: No
  • Generic name: lifitegrast
  • Company: Shire US, Inc.
  • Treatment for: Dry Eye Disease

Lifitegrast is an investigational integrin antagonist for the topical treatment of dry eye disease.

Development Status and FDA Approval Process for lifitegrast

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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