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Lilly receives approvable letter for Arxxant

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INDIANAPOLIS — Eli Lilly and Co. has received an "approvable" letter from the Food and Drug Administration for ruboxistaurin mesylate, an investigational oral therapy for diabetic retinopathy, the company announced in a press release. The proposed trade name for the drug is Arxxant.

The FDA has requested additional data to support the evidence provided in Lilly's new drug application for Arxxant, according to the company. Lilly plans to meet with the FDA to determine whether a new study is required, or if they can satisfy the request with data from a current study.

Lilly and Alcon recently announced a long-term agreement to jointly market the drug in the United States and Puerto Rico, pending its FDA approval. Alcon will market the drug to eye specialists, including retinal specialists and general ophthalmologists. Lilly will assume primary responsibility for marketing to endocrinologists and primary care physicians.