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Tuesday, Apr 23, 2024

Drug Maker Ista Asks FDA to Not Approve Rival Generic

Irvine drug maker Ista Pharmaceuticals Inc. said Friday it asked the Food and Drug Administration to reject a generic version of its drug for treating eye pain after cataract surgery.

The drug maker said it made the request out of safety concerns. Competitive issues also could be a factor.

Ista didn’t name the generic maker.

It’s believed to be Switzerland’s Alcon Inc., which has filed for approval of bromfenac sodium, a generic version of Ista’s Xibrom for pain after cataract surgery.

Ista stopped selling a twice-daily version of Xibrom last month after it came out with a once-daily version called Bromday.

Alcon’s version would be used twice daily.

The FDA has raised safety concerns about Xibrom and similar drugs, cautioning that patients should take the lowest effective dose.

Ista calls Bromday the lowest effective dose version of the drug.

Even with concerns, Bromday could face competition from a generic, twice daily version of the drug.

Ista has requested that regulators require any twice daily generic include label wording indicating that a once daily version is preferred.

Xibrom has been Ista’s historical flagship drug, accounting for about 70% of the company’s annual sales of more than $150 million.

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