Lilly Gets Approvable Letter for Arxxant

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Eli Lilly and Co. received an approvable letter from the FDA for ruboxistaurin mesylate (proposed trade name Arxxant), its investigational oral therapy for treatment of diabetic retinopathy (DR), a diabetic eye disease. As part of the letter, the FDA has requested additional data to support the clinical evidence presented by the company in its NDA. Lilly plans to meet with the FDA to determine whether this request can be satisfied with data from an ongoing study or whether a new study is re...

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