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Home Industry News Lilly to receive extension to FDA review of exenatide

Lilly to receive extension to FDA review of exenatide

26th February 2010

Lilly has been given a new action date by the Food and Drug Administration (FDA) for its review of the company’s new diabetes drug exenatide.

The FDA has decided to add an extra five days to its review period of Lilly’s new drug application for the once-weekly treatment due to the recent disruption of the regulator’s activities by the extreme weather conditions.

It has now established March 12th 2010 as its new action date for the review, which has been ongoing since the company’s application was accepted in July 2009.

Exenatide has been developed by Lilly in collaboration with fellow pharmaceutical companies Amylin and Alkermes and is an extended-release treatment which delivers continuous therapeutic levels in a single dose.

It has not been approved by any global regulatory agencies thus far.

Earlier this week, Lilly revealed plans to work together with Pfizer and Merck Sharpe and Dohme on a new cancer research initiative in Asia.

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