pSivida Corp. PSDV today announced that its licensee, Alimera Sciences, Inc., resubmitted a New Drug Application for the investigational drug ILUVIEN® for the treatment of diabetic macular edema to the U.S. Food and Drug Administration on May 12, 2011 to address questions raised in the Complete Response Letter Alimera received in December 2010.
Alimera reported that according to the FDA's classification scheme, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act, FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received.
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