Friday, Skyepharma Plc (SKP.L) announced that the New Drug Application or NDA for Flutiform in the U.S. is being transferred to SkyePharma.
As announced earlier, following receipt of the Complete Response Letter in January, discussions are being sought with the U.S. Food and Drug Administration or FDA as soon as possible to determine what steps would need to be taken before the application for Flutiform can be approved. The transfer of the NDA will enable SkyePharma to deal directly with the FDA in these discussions.
SkyePharma and its U.S. licensing partner, Abbott Respiratory LLC, are working together on the transfer of the NDA and will consider implications for Flutiform in the U.S. in due course.
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