The agency now appears likely to extends its review of the injectable diabetes med, which Lilly and Amylin Pharmaceuticals want approved as a stand-alone treatment, into next year. The FDA, however, apparently did not request additional studies, but is reviewing prescribing info and wants safety language revised, according to a statement from the drugmakers.

Byetta has caused all sorts of turmoil for Lilly and Amylin this year, thanks to reports of pancreatitis. A total of four deaths were reported this past summer (look here), and a subsequent slowdown in sales contributed to a 25 percent staff reduction last month (see here).

Amylin and Lilly are also developing a long-acting version of Byetta known as exenatide LAR, although its fate is unclear due to Byetta’s safety concerns. And last month, the FDA rejected study data that was meant to show that exenatide LAR batches made at one plant were equivalent to batches made at another facility (back story).