ISTA Pharmaceuticals Files Citizen Petition (CP) With U.S. Food And Drug Administration
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), announced it filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) on March 1, 2011. The CP requests the FDA refrain from granting tentative or final approval of any abbreviated new drug application (ANDA) for bromfenac sodium ophthalmic solution 0.09% that utilizes the labeling for discontinued XIBROM (bromfenac ophthalmic solution)(R) 0.09% or omits any portion of the BROMDAY label relating to the once-per-day dosing.