Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN® to the U.S. Food and Drug Administration (FDA). At this time, Alimera awaits the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. Alimera intends to provide that information when it becomes available.
In the resubmission, Alimera responded to questions raised in the FDA's October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe.
"We are pleased to resubmit ILUVIEN for approval in the United States," said Dan Myers, Alimera's president and chief executive officer. "We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed."
SOURCE Alimera Sciences, Inc.