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SkyePharma gets expected complete response letter for Flutiform

This article was originally published in Scrip

Executive Summary

The US FDA has issued a complete response letter to Skyepharma, denying approval for its lead candidate, the asthma drug Flutiform (fluticasone propionate plus formoterol fumarate). The letter does not come as a surprise; the agency gave preliminary notice of review issues in June, and SkyePharma said in September that more trials to better assess dosing would be needed to achieve approval (scripnews.com, September 2nd, 2009).

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