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Insulin
Exenatide new drug application accepted for review by the FDA
September 27th, 2004
Amylin Pharmaceuticals, Inc., (AMLN) and Eli Lilly and Co. (LLY) announced that the new drug application (NDA) for exenatide has been accepted for review by the U.S. Food and Drug Administration (FDA). Exenatide is the first potential therapy in a new class of drugs under investigation for the treatment of type 2 diabetes known as incretin mimetics. The NDA for exenatide was submitted to the FDA on June 29, 2004. The Prescription Drug User Fee Act goal date is April 30, 2005. "This is an important step in the regulatory process as we work to transition exenatide from an investigational agent to the marketplace, providing an additional therapy to...
Source: Obesity & Diabetes Week (2004-09-27)
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