Keywords: SkyePharma, Abbott Labs, Flutiform, NDA, FDA, Licensing
SkyePharma takes back NDA for Flutiform from Abbott Labs
Article | 8 February 2010
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. Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.
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