US FDA APPROVES BYDUREON® PEN (EXENATIDE EXTENDED-RELEASE FOR INJECTABLE SUSPENSION) FOR ONCE-WEEKLY TREATMENT OF ADULTS with TYPE 2 DIABETES AstraZeneca today announced that the US Food and Drug ...
BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 ...
In clinical trials, treatment with Bydureon BCise resulted in average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds when used as monotherapy or as an add-on to metormin, a ...
BYDUREON (exenatide extended-release for injectable suspension) 2mg/vial by Amylin and Alkermes Amylin and Alkermes announced that the FDA has approved Bydureon (exenatide extended-release for ...
With a view to improve treatment for diabetes patients through innovative technology, product design and development firm Cambridge Consultants in association with AstraZeneca have developed Bydureon ...
BYDUREON BCISE The expanded approval was based on data from a phase 3 study that evaluated exenatide extended-release in 82 patients aged 10 to 17 years with type 2 diabetes. The Food and Drug ...
SAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Mar 03, 2011 (BUSINESS WIRE) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today ...
Eli Lilly and Company together with Amylin Pharmaceuticals, Inc. and Alkermes, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ...
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced the US Food and Drug Administration (FDA) has approved BYDUREON ® (exenatide extended-release) for injectable suspension as an add-on ...
Silver Spring, MD - The US Food and Drug Administration (FDA) last week approved a once-weekly extended-release formulation of exenatide injection (Bydureon, Amylin Pharmaceuticals) as an adjunct to ...
October 29, 2010 — The FDA has issued a complete response letter regarding a once-weekly extended-release formulation of exenatide injection (Bydureon; Eli Lilly and Co; Amylin Pharmaceuticals, Inc; ...