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Ista submits supplemental new drug application for once-daily bromfenac ophthalmic solution

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IRVINE, Calif. — Ista Pharmaceuticals has submitted a supplemental new drug application to the U.S. Food and Drug Administration for a once-daily dose of bromfenac ophthalmic solution for treating ocular inflammation and pain after cataract surgery, the company announced.

Ista expects the FDA to undertake a standard 6-month review after the formal date of receipt. If approved, the company plans to market the once-daily dose under the brand name XiDay.

Ista currently markets a twice-daily dose of Xibrom (bromfenac ophthalmic solution 0.09%) for use 24 hours after cataract surgery. However, Xibrom has not been approved by the FDA as a once-daily dose.

Ista's new drug application calls for the FDA to approve a label change for bromfenac ophthalmic solution to indicate its efficacy as a once-daily treatment.