Published on March 8, 2010 at 11:54 PM
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay™ (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has granted XiDay a standard review time of ten months, assigning ISTA a Prescription Drug User Fee Act (PDUFA) action date of October 16, 2010. ISTA's request for a shorter, six-month priority review is still under consideration by the FDA.
SOURCE ISTA Pharmaceuticals, Inc.