ISTA planning on FDA approval for bromfenac label change
ISTA Pharmaceuticals is planning to ask the FDA to approve a change to the label of its bromfenac 0.09% ophthalmic solution. It has obtaining positive preliminary phase III results in a confirmatory clinical study of once-daily bromfenac (Xibrom QD) for the treatment of inflammation and pain after cataract surgery. The topical non-steroidal anti-inflammatory compound currently is labeled for twice-daily use beginning 24 hours after such surgeries.
- ISTA Pharma won the FDA support for Bepreve eye drops
- Bepreve approved by the FDA
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- Allergan-Asterand agreement for compounds
