Alimera, FDA enter labeling discussions regarding Iluvien

Alimera Sciences and the U.S. Food and Drug Administration have begun discussing labeling for the Iluvien implant, and as a result, the company is not required to participate in the Dermatologic and Ophthalmic Drugs Advisory Committee meeting scheduled for Jan. 27. According to a press release from Alimera, the company will draft a response to a complete response letter it received from the FDA in October and submit it in the first quarter of 2014. Alimera intends to address concerns the FDA raised regarding the facility where Iluvien (sustained-release fluocinolone (Read more...)

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