ISTA Pharmaceuticals Loses as Court Rejects Claim FDA Wrongly Approved Xibrom Generic

ISTA Pharmaceuticals Inc. lost its bid to secure a court order forcing the Food and Drug Administration to rescind its approval of a generic version of ISTA’s ophthalmic nonsteroidal anti-inflammatory drug Xibrom (bromfenac ophthalmic solution, 0.09 percent) after a federal court July 9 found the approval did not violate the law (ISTA Pharmaceuticals Inc. v. FDA, D.D.C., 1:11-cv-00907-JSG, 7/9/12).

Granting summary judgment in favor of FDA, Judge James Gwin of the U.S. District Court for the Northern District of Ohio, sitting by designation in the U.S. District Court for the District of Columbia, found that FDA’s decision ...