ISTA Pharmaceuticals, Inc. announced that the US Food & Drug Administration (FDA) plans to complete review of ISTA's Vitrase for use as a spreading agent New Drug Application (NDA) by May 5, 2004, a 90-day extension of the original action date. According to the FDA's written notification to ISTA, the extension will allow "full review of the submission," including the company's amendment to the NDA submitted late last year. Under the Prescription Drug User Fee Act (PDUFA), the FDA can reset the action date to review additional data submitted within three months of the original PDUFA action date.
"We have maintained close contact with the agency throughout the process of filing the NDA and believe that any remaining issues can be resolved within the extension period," stated Vicente Anido, Jr., ISTA's CEO. "We very much look forward to working closely with the FDA to complete their review within the extended period."