Feedback for Novo Nordisk's Victoza Delayed by FDA

Feedback for Novo Nordisk's Victoza Delayed by FDA

On Wednesday, prominent Danish pharmaceutical company Novo Nordisk shared that the formal feedback that the company was expecting on its Victoza diabetes drug has been delayed by the US Food and Drug Administration beyond 2009, but it is expected "within weeks".

Also marketed as liraglutide, victoza, was approved for sale across Europe in July, but there have been repeated delays in gaining approval for US marketing, which is much important for the company.

Analysts were expecting to hear the happy news of an approval by the end of the year, and the delay could overshadow the Novo Nordisk's performance for the year.

"Formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide, a once-daily human GLP-1 analogue, is expected within week. Novo Nordisk continues the constructive dialogue with the FDA regarding the regulatory process for liraglutide", the company said in an official statement released regarding the development.

Also, the company has confirmed that if a formal feedback is not received by February 2, 2010, it would provide an update on the regulatory process along with its report for the 2009 financial year.

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