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More data on dosing needed for Flutiform

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

SkyePharma receives a 74-day letter from FDA for its asthma treatment Flutiform (fluticasone/formoterol inhalation aerosol), noting that although its NDA is "sufficiently complete," based on FDA's preliminary assessment it is "likely" that further clinical work would be required for approval - specifically to accumulate additional data on dosing. SkyePharma is seeking further clarification of review issues. Flutiform is a fixed-dose combination of formoterol and the inhaled steroid fluticasone in a metered dose inhaler. The U.K.-based drug delivery company is partnering with Abbott in the U.S. and Mundipharma in the EU, where Flutiform is expected to be filed for approval in the first quarter of 2010. The application was submitted to FDA in March 2009 and accepted May 22, 2009

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