increased incidence of pancreatitis reported 4/09, and could delay LAR approval; NDA filed 5/09 and accepted 7/09; superior glucose control vs. Lantus reported 7/09; PDUFA date 3/5/2010, but changed to 3/12/10; Complete response letter received (3/10), which indicates no new clinical trials needed, rather issues with product labeling with accompanying REMS strategy and clarification of existing manufacturing processes; FDA regulator notes possible link to higher risk of cancer, similar to Victoza (4/10); response sent to FDA 4/10, with expected review within 2-6 months; new PDUFA date 10/22/10; phase III data shows 1.5% reduction in A1C vs Januvia, but demonstrated non-inferiority to generic metformin and Actos (6/10)
Brand Bydureon (also known as Byetta LAR) Generic exenatide
Company name Amylin Product type Non-speciality
Therapeutic category Endocrine and Diabetes Key uses Diabetes
Other Uses N/A Drug Class incretin mimetic
Dosage From SC Expected Approval 2010-Q4
FDA Filing 5/09 Last Update date June 29,2010
Link to published study
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Link to clinicaltrials.gov
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