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Home Industry News Lilly receives FDA response over exenatide application

Lilly receives FDA response over exenatide application

17th March 2010

Lilly has received a complete response letter from the Food and Drug Administration (FDA) in relation to its application for approval of the diabetes treatment exenatide.

The company and its collaborative partners Amylin and Alkermes have been asked to clarify certain issues relating to its manufacturing process, as well as providing risk management information for the product’s labelling.

However, the regulator did not request any new clinical trials and was satisfied that pre-approval observations at the intended manufacturing facility in Ohio have now been addressed.

Dr Orville Kolterman, senior vice president of research and development at Amylin Pharmaceuticals, described the response as a “significant step forward” in the development of the drug, which will be sold under the name Bydureon.

He added: “We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”

Earlier this week, Lilly agreed a deal to license and commercialise Axiron, a new treatment for testosterone deficiency developed by Acrux.

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