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Xibrom Approval History

  • FDA approved: Yes (First approved March 24th, 2005)
  • Brand name: Xibrom
  • Generic name: bromfenac
  • Dosage form: Ophthalmic Solution
  • Company: ISTA Pharmaceuticals, Inc.
  • Treatment for: Postoperative Ocular Inflammation

Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction.

Development History and FDA Approval Process for Xibrom

Jan 27, 2006Approval Xibrom - ISTA Pharmaceuticals, Inc. - New Indication Approved
Mar 24, 2005Approval Xibrom ISTA Pharmaceuticals, Inc. - Treatment for Ocular Inflammation Following Cataract Surgery
Jul 26, 2004FDA Accepts ISTA Pharmaceuticals' New Drug Application for Xibrom
May 25, 2004ISTA Pharmaceuticals Announces Submission of Xibrom NDA to the FDA

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