ANI Pharmaceuticals announces FDA approval for expansion of Iluvien label

ANI Pharmaceuticals (ANIP) announced that the U.S. FDA has approved an expanded label for Iluvien that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The approval also includes other updates to the label including to the Warnings and Precautions section. As previously announced, the company plans to market Iluvien for chronic NIU-PS in addition to its current indication of diabetic macular edema in the U.S. Iluvien is already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries.