In the continuing saga that is Bydureon approval (or not) by the FDA, we at least now have a formal date for the next decision. The three partners in crime Amylin Pharmaceuticals, Alkermes and Eli Lilly said today that the FDA has set a deadline of Jan. 28 to complete its review of the updated application for exenatide once-weekly (Bydureon). The companies are seeking FDA clearance to start marketing the new product as the first once-weekly injectable medicine for diabetes patients in the U.S. The drug was approved in the European Union in June. See Xconomy.
Once approved - Amylin and Lilly can decide whether they will actually try selling the product together or keep on suing each other over Byetta/linagliptin spat.
Posted by Bruce Lehr Aug 12th 2011