FDA expands indication for bromfenac use

Irvine, CA-ISTA Pharmaceuticals Inc. announced that the FDA has approved its supplemental new drug application (sNDA) for bromfenac ophthalmic solution 0.09% (Xibrom). The indication expands bromfenac's indication to include the treatment of pain following cataract surgery.

Bromfenac, a topical, twice-daily, non-steroidal anti-inflammatory solution, was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract surgery.

ISTA launched the drug in the United States during the second quarter of 2005.