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FDA grants Ista 3-year market exclusivity for Bromday

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IRVINE, Calif. — The U.S. Food and Drug Administration has granted Ista Pharmaceuticals 3 years of marketing exclusivity for once-daily bromfenac ophthalmic solution 0.09%, the company announced in a press release.

Bromday (bromfenac ophthalmic solution 0.09%), formerly called XiDay, was approved by the FDA in October for treating postoperative inflammation and pain in patients after undergoing cataract extraction.

Ista has already begun shipping Bromday to wholesalers and expects the drug to be available in pharmacies beginning Nov. 22. Accordingly, Ista will discontinue marketing twice-daily Xibrom (bromfenac ophthalmic solution 0.09%) early next year.

Under the aegis of the Drug Price Competition and Patent Term Restoration Act, also know as the Hatch-Waxman Act, the FDA may still opt to deny Ista's Abbreviated New Drug Application for a generic version of Bromday until October 2013.