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Ista files citizen petition regarding approval of bromfenac solutions

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IRVINE, Calif. — Ista Pharmaceuticals has filed a citizen petition with the U.S. Food and Drug Administration, requesting it not approve any abbreviated new drug application for bromfenac sodium ophthalmic solution 0.09% that uses labeling from discontinued Xibrom or leaves out any once-daily dosing instructions, the company announced in a press release.

Ista filed the petition after the FDA questioned the safety of ophthalmic nonsteroidal anti-inflammatory drugs, saying that patients who receive the drugs after cataract surgery should receive the lowest effective dose, the release said.

According to Ista's head-to-head study between once-daily Bromday (bromfenac sodium ophthalmic solution 0.09%) and once-daily bromfenac sodium 0.18%, Bromday is the lowest-effective dose for postoperative inflammation and pain after cataract surgery.

Bromday was approved by the FDA in October 2010, after Ista changed Xibrom's (bromfenac ophthalmic solution 0.09%) dosing instructions from twice daily to once daily.

The FDA is required to respond to the citizen petition within 180 days of receiving it, the release said.