YEAH ! It's done ! its recent resubmission of the New Drug Application (NDA) for ILUVIEN® has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 has been established.
At last ALIM will have a the chance to prove its point of view.
In the resubmission, Alimera responded to questions raised in the FDA's letter and provided additional analyses as well as new information to support that ILUVIEN is safe and effective in the treatment of patients with chronic diabetic macular edema (DME).