Xibrom FDA Approval History
FDA Approved: Yes (Discontinued) (First approved March 24, 2005)
Brand name: Xibrom
Generic name: bromfenac
Dosage form: Ophthalmic Solution
Company: Bausch & Lomb Inc.
Treatment for: Postoperative Ocular Inflammation
Marketing Status: Discontinued
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 Timeline for Xibrom
|Jan 27, 2006||ApprovalXibrom - ISTA Pharmaceuticals, Inc. - New Indication Approved|
|Mar 24, 2005||ApprovalXibrom ISTA Pharmaceuticals, Inc. - Treatment for Ocular Inflammation Following Cataract Surgery|
|Jul 26, 2004||FDA Accepts ISTA Pharmaceuticals' New Drug Application for Xibrom|
|May 25, 2004||ISTA Pharmaceuticals Announces Submission of Xibrom NDA to the FDA|
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