Posted on 05/11/2009 in Pharmaceutical Company Product News Lilly and Amylin have offered an update on their Food and Drug Administration (FDA) application for the injection Byetta (exenatide).
The product, on which the firms collaborated, was approved by the FDA on October 30th 2009, but now includes more indications for its use as a stand-alone therapy.
It is designed for, along with diet and exercise, the improvement of glycemic control in adults with type 2 diabetes.
As well as the monotherapy indication, the FDA approved changes to the Byetta prescribing instructions to incorporate updated safety information.
Orville Kolterman, senior-vice president of research and development at Amylin Pharmaceuticals, stated: "We remain committed to working closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products."
Lilly recently posted its third-quarter financial results, which showed that its total reported revenue for the period stood at $5,562 million (3.4 million pounds), compared to $5,209 million during the same period of 2008.
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