Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant TM Aug 19th 2006
Eli Lilly and Company announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for ruboxistaurin mesylate... 
(proposed trade name Arxxant(TM), pronounced, ark-ZONT), its investigational oral therapy being studied for treatment of diabetic retinopathy (DR), a diabetic eye disease.
In its letter, the FDA has requested submission of additional data to support the clinical evidence presented by Lilly in its new drug application (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 required.
We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward, said Dr. Timothy R. Franson, Vice President of Global Regulatory Affairs, Eli Lilly and Company.
Eli Lilly and Company http://www.lilly.com/index.html
Aug 19th 2006
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