BioCentury
ARTICLE | Company News

FDA accepts resubmitted Iluvien NDA

April 15, 2014 12:23 AM UTC

Alimera Sciences Inc. (NASDAQ:ALIM) said FDA accepted for review a resubmitted NDA for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema (DME). The PDUFA date is Sept. 26. In October, FDA issued a complete response letter for the injectable insert that delivers fluocinolone acetonide to the retina. Alimera markets Iluvien in Europe (see BioCentury Extra, Dec. 18, 2013). ...