Bydureon definition

Bydureon means a once weekly Exenatide injectable, and includes, without limitation, all delivery devices and other peripherals and consumables used in connection with the administration thereof. For clarity, Bydureon is not an Exenatide Suspension Product.
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Examples of Bydureon in a sentence

  • Bydureon has been shown to provide powerful HbA1c reduction of 1.3~1.9%.

  • AstraZeneca submitted manufacturing application for Bydureon in China in May 2016.

  • Bydureon is an extended-release formulation of exenatide, administered once weekly as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, which is indicated for treatment of patients who have not achieved adequate glycaemic control on metformin, sulphonylureas, thiazolidines, metformin plus sulphonylureas or thiazolidines, or sulphonylureas plus thiazolidines.

  • The inVentiv Sales Representatives shall be managed by thirty-six (36) Associate Directors (30 for Bydureon and 6 for Symlin), one National Business Director (with support from an on-site Project Liaison on-site at Client, and at no cost to Client, and appropriate project management support (collectively, the “Management Team” and the Management Team with the inVentiv Sales Representatives, the “Project Team”), all of whom shall be inVentiv employees.

  • Bydureon was approved by the Food and Drug Administration in the US in 2012.

  • The Licensed Products are Byetta, Bydureon single dose tray, Bydureon dual chamber pen and Bydureon auto-injector, the details of which are set forth in the Exclusive License Agreement.

  • Bydureon is currently available in 42 countries worldwide, including European Union countries.

  • Since Bydureon BCise, the NPM-119 reference drug, did not demonstrated a reduction in cardiovascular morbidity and mortality, NPM-119 will not have this claim in the approved product label unless NPM generates positive CVOT data with NPM-119.

  • Bydureon) or (ii) based upon or arising out of conduct affecting only a specific batch or portion of the product (including, but not limited to, manufacturing issues) manufactured on or after the Effective Date, Amylin shall be responsible for the defense (including, without limitation, the funding therefor) of both Lilly and Amylin with respect thereto and will be fully responsible for the total cost of any settlements or judgments.

  • The Party that is the holder of the Regulatory Approval for Byetta or Bydureon in a country shall have control, in consultation with the other Party, over whether to conduct a recall or market withdrawal of Byetta or Bydureon, as applicable, in such country and the manner in which any such recall or market withdrawal shall be conducted.