USFDA is continuing with its review of the regulatory application for use of Amylin's and Eli Lilly's BYETTA(R) (exenatide) injection as a stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will not be complete by the end of 2008, and may extend into 2009. The regulatory application for use of BYETTA as monotherapy was submitted in the first quarter of 2008. The FDA is also reviewing several other BYETTA prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labeling to the new standard format.
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