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Ophthalmic NSAID gains expanded indication

February 6, 2006

The FDA has approved ISTA's supplemental New Drug Application (sNDA) for Xibrom (bromfenac topical ophthalmic solution) 0.09%, expanding Xibrom's indications to include the treatment of pain following cataract surgery. Xibrom, a topical, twice-daily NSAID, was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract surgery.