FDA Denies Approval of Once a Week Byetta Diabetes Drug

Boston (DbTechNo) – The FDA have denied approval of a once a week version of Byetta, a diabetes drug made by Amylin and Lilly.

Byetta is a blockbuster drug approved to treat type 2 diabetes, and has annual sales topping the 700 million dollar mark.

The agency may have thought twice about approving the once a week version of the drug after they detected short-comings at an Amylin manufacturing plant.

According to the agency, who sent the companies a complete response letter, they also asked for additional information on the drug specifically dealing with its labelling.

The agency did not ask for any additional clinical trials to be conducted, so the drug may have reached the end of the line as far as the once a week version of it is concerned.

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