SkyePharma takes back NDA for Flutiform from Abbott Labs

The UK's drug formulation specialist SkyePharma says that the US New Drug Application for its investigation asthma drug Flutiform (fluticasone propionate/formoterol fumarate) is being transferred to the company from US licensing partner Abbott Laboratories.

As previously announced, following receipt of the Complete Response Letter in January, discussions are being sought with the US Food and Drug Administration as soon as possible to determine what steps would need to be taken before the application for Flutiform can be approved. At that time, the FDA said there were "substantive" issues that needed to be resolved ahead of an approval, although the UK firm noted that this is not expected to have an impact on the development f the drug in Europe or Japan. SkyePharma believes the transfer of the NDA will enable it to deal directly with the FDA in these discussions.

SkyePharma and Abbott are working together on the transfer of the NDA and will consider implications for Flutiform in the USA in due course, the UK firm noted.