Alimera Sciences, Inc. (ALIM), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, Wednesday said its recent resubmission of the New Drug Application for Iluvien has been acknowledged as received by the U.S. Food and Drug Administration as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act or PDUFA goal date of October 17 has been established.
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.
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