FDA sets review for Amylin diabetes drug
The U.S. Food and Drug Administration has set a January 28, 2012 deadline for its review of a diabetes drug being developed by Amylin Pharmaceuticals Inc, Eli Lilly and Co and Alkermes Inc.
The companies submitted an application for the drug, Bydureon, last month after the regulatory agency declined on two separate occasions to approve it.
The FDA asked last year for more data on Bydureon's impact on the heart before deciding whether to clear it as a treatment for Type 2 diabetes.
Amylin said in early July that a trial of exenatide, the active ingredient in Bydureon, found no link between the drug and changes in heart rhythms.
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