According to diabetes news today, Amylin Pharmaceuticals Inc revealed that they had received a request from the Food and Drug Administration for information about manufacturing and a risk mitigation plan for their proposed once a week diabetes treatment .
Amylin have partnered with Eli Lilly and Company as well as Alkermes Inc. The FDA has requested a focus on product labelling for the new diabetes drug Bydureon (trade name for exenatide.) The FDA also require risk mitigation data and manufacturing information, which Amylin will now work to supply.
Exenatide is a once-per-week version of injectable diabetes treatment Byetta, currently being taken twice per day by thousands of diabetes patients in the UK. The drug will be one of the first in the GLP-1 class, to accompany the Novo Nordisk drug Victoza .
Food and Drug Administration call for more information on Amylin diabetes drug
Sat, 20 Mar 2010
Recommended links
Diabetes forumDiabetes myLifestyle
Diabetes donate
Diabetes symptoms
Diabetes pensions and annuities
Diabetes.co.uk ID alert wristband
The Diet Plate to help control diabetes
Diabetes injection Byetta LAR faces Food and Drug Administration decision
Food and Drug Administration say diabetes patients should not stop taking Avandia
Type 2 diabetes drug gets Food and Drug Administration approval
Join us