Ista, Mylan sales and marketing update

Mylan launched a generic version of Ista's Xibrom 0.09% bromfenac ophthalmic solution in the U.S. to treat ocular inflammation and pain following cataract surgery. FDA approved a generic version of the twice-daily solution on May 12 after Ista submitted a Citizen's Petition to FDA on March 1 asking the agency to not grant tentative or final approval of ANDAs for the solution. On May 13, Ista lodged a complaint in the U.S. District Court for the District of Columbia alleging that FDA's approval of an ANDA for bromfenac sodium was arbitrary, capricious and contrary to law. The company also sought a temporary restraining order and preliminary injunction mandating rescission of the approval (see BioCentury, March 14). ...