Industry News — Clinical Updates

Alimera Announces PDUFA Goal Date for Iluvien

Alimera Sciences, Inc. (Atlanta, GA) has announced that its recent resubmission of the New Drug Application (NDA) for Iluvien (sustained-release fluocinolone acetonide implant) has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's October 2013 letter. The FDA has set September 26, 2014 as the Prescription Drug User Fee Act (PDUFA) goal date.

In the resubmission, Alimera responded to questions raised in the FDA's October 2013 letter and provided data from Iluvien patients and from physician experience with the applicator in the United Kingdom and Germany, where Iluvien is currently commercially available. Iluvien has also received marketing authorization in Austria, the United Kingdom, Portugal, France, Germany, and Spain.

Also read: Alimera Resubmits New Drug Application for Iluvien

Updated April 15, 2014