ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label

BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). 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 (DME) in the U.S. ILUVIEN is already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries.

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ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label