Monotherapy Update - Delayed! Amylin, Lilly Update on FDA Review of BYETTA(R) (exenatide) Injection Monotherapy Submission It is likely that this review will not be complete by the end of 2008, and may extend into 2009.
3years ago the FDA gave Amylin a approvable letter when Byetta BID was approved.Monotherapy should be a simple task,even for these incompetents... If its politics( new admin soon ) or whatever its safe to say Pharmas are in big trouble in trying to get anything approved. Sad,the drug industry is one of the few we lead in in the world, give the Govt a chance to screw it up