FDA to review sNDA for bromfenac

Irvine, CA

-The FDA has accepted for review the supplemental new drug application (sNDA) of ISTA Pharmaceuticals Inc. for once-daily bromfenac ophthalmic solution (XiDay), according to the company.

The agency has granted a standard review time of 10 months, assigning ISTA a Prescription Drug User Fee Act action date of Oct. 16. The company’s request for a shorter, 6-month priority review also is under consideration by the FDA, ISTA said.

ISTA currently markets bromfenac ophthalmic solution 0.09% (Xibrom), an eye drop formulation of a non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. That drug, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for the drug in 2002 and launched the product in the United States in 2005.