Eli Lilly and Company has received an approvable letter from the FDA requesting additional supporting data for its new drug application for ruboxistaurin mesylate (proposed trade name: Arxxant), Lilly’s investigational oral therapy for diabetic retinopathy.
The company plans to meet with the FDA to determine whether a new study is required to meet the request or if data from an ongoing study will suffice.
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“We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward,” said Timothy R. Franson, MD, the company’s vice president of global regulatory affairs.
